| Drug/Strength |
Petition No./Firm |
Dosage Form |
Status |
Status Date |
ACETAMINOPHEN 500 MG
CODEINE PHOSPHATE 30 MG OR 60 MG
|
84P-0228/CP1
MCNEIL
|
CAPSULE |
Withdrawn |
3/26/2007 |
METHYLTESTOSTERONE 25 MG
|
85P-0067/CP
STAR PHARMS
|
CAPSULE |
Withdrawn |
3/26/2007 |
HYDRALAZINE HYDROCHLORIDE 25 MG/5ML
|
85P-0074/CP
ROXANE
|
ORAL SOLUTION |
Withdrawn |
3/26/2007 |
FLURAZEPAM HYDROCHLORIDE 30 MG/ML
|
85P-0081/CP
ROXANE
|
ORAL SOLTUION |
Withdrawn |
3/26/2007 |
BROMPHENIRAMINE MALEATE 12 MG
PSEUDOEPHEDRINE HYDROCHLORIDE 120 MG
|
83N-0095/CP
UAD LABS
|
EXTENDED-RELEASE CAPSULE |
Withdrawn |
3/26/2007 |
FLURAZEPAM HYDROCHLORIDE 15 MG/5ML
|
85P-0091/CP
ROXANE
|
ORAL SOLUTION |
Withdrawn |
3/26/2007 |
VINCRISTINE SULFATE 2 MG
|
85P-0084/CP
BRISTOL
|
FOR INJECTION |
Withdrawn |
3/26/2007 |
PROPRANOLOL HYDROCHLORIDE 160 MG
|
85P-0129/CP
VEREX
|
EXTENDED-RELEASE TABLET |
Withdrawn |
3/26/2007 |
LORAZEPAM 0.5 MG, 1 MG OR 2 MG
|
85P-0515/CP
WYETH
|
TABLET (FAST-DISSOLVING) |
Withdrawn |
3/26/2007 |
DEXBROMPHENIRAMINE MALEATE 6 MG
PSEUDOEPHEDRINE HYDROCHLORIDE 120 MG
|
85P-0140/CP
CENTRAL PHARMS
|
EXTENDED-RELEASE CAPSULE |
Withdrawn |
3/26/2007 |
KETOCONAZOLE 20 MG/ML
|
85P-0147/CP
JANSSEN
|
ORAL SUSPENSION |
Withdrawn |
3/26/2007 |
PROPRANOLOL HYDROCHLORIDE 80 MG, 120 MG, 160MG
|
85P-0197/CP
FOREST PHARMS
|
EXTENDED-RELEASE TABLET |
Withdrawn |
3/26/2007 |
DISULFIRAM 500 MG/30 ML
|
85P-0215/CP
PADDOCK
|
ORAL SUSPENSION |
Withdrawn |
3/26/2007 |
DEXBROMPHENIRAMINE MALEATE 6 MG
PHENYLPROPANOLAMINE HYDROCHLORIDE 75 MG
|
85P-0238/CP2
BOCK PHARMA
|
EXTENDED-RELEASE CAPSULE |
Withdrawn |
3/26/2007 |
CODEINE PHOSPHATE 10 MG/5 ML
DEXBROMPHENIRAMINE MALEATE 1 MG/5 ML
|
85P-0269/CP
BOCK PHARMA
|
SYRUP |
Withdrawn |
3/26/2007 |
BENZTROPINE MESYLATE 0.5 MG/5 ML
|
85P-0423/CP
RIM CONSULTING
|
SYRUP |
Withdrawn |
3/26/2007 |
AZATADINE MALEATE 1 MG
PHENYLPROPANOLAMINE HYDROCHLORIDE 75 MG
|
85P-0492/CP
SKF
|
EXTENDED-RELEASE CAPSULE |
Withdrawn |
3/26/2007 |
DIAZEPAM 2 MG/5 ML
|
85P-0499/CP
CAROLINA MEDCL
|
SYRUP |
Withdrawn |
3/26/2007 |
SPIRONOLACTONE 25 MG/5 ML
|
85P-0510/CP
CAROLINA MEDCL
|
SYRUP |
Withdrawn |
3/26/2007 |
OXAZEPAM 15 MG OR 30 MG
|
85P-0516/CP
WYETH
|
TABLET |
Withdrawn |
3/26/2007 |
ACETAMINOPHEN 300 MG
CODEINE PHOSPHATE 30 MG
|
85P-0543/CP
SOFTAN
|
SOFT GELATIN CAPSULE |
Withdrawn |
3/26/2007 |
ACETAMINOPHEN 500 MG
CODEINE PHOSPHATE 7.5 OR 15 MG
|
85P-0543/CP2
SOFTAN
|
SOFT GELATIN CAPSULE |
Withdrawn |
3/26/2007 |
DEXBROMPHENIRAMINE MALEATE 6 MG
PSEUDOEPHEDRINE SULFATE 120 MG
|
85P-0140/CP2
CENTRAL PHARMS
|
EXTENDED-RELEASE CAPSULE |
Withdrawn |
3/26/2007 |
IBUPROFEN 300, 400 OR 600 MG
|
85P-0563/CP
SOFTAN
|
SOFT GELATIN CAPSULE |
Withdrawn |
3/26/2007 |
ACETAMINOPHEN 500 MG
OXYCODONE HYDROCHLORIDE 5 MG
|
85P-0543/CP3
SOFTAN
|
SOFT GELATIN CAPSULE |
Withdrawn |
3/26/2007 |
ACETAMINOPHEN 500 MG
PROPOXYPHENE HYDROCHLORIDE 32 MG
|
85P-0581/CP
SOFTAN
|
SOFT GELATIN CAPSULE |
Withdrawn |
3/26/2007 |
PROPRANOLOL HYDROCHLORIDE 10,20,40,60,80,90 MG
|
86P-0045/CP
NUTRIPHARM LABS
|
CAPSULE |
Withdrawn |
3/26/2007 |
SPIRONOLACTONE 25 MG/5 ML
|
86P-0055/CP
CAROLINA MEDCL
|
ORAL SUSPENSION |
Withdrawn |
3/26/2007 |
CHOLESTYRAMINE 4 GM
|
86P-0123/CP
PARKE DAVIS
|
CHEWABLE TABLET |
Withdrawn |
3/26/2007 |
DISOPYRAMIDE PHOSPHATE 200 MG OR 300 MG
|
84N-0116/CP
BIOCRAFT
|
EXTENDED-RELEASE TABLET |
Withdrawn |
3/26/2007 |
ACETAMINOPHEN 650 MG
CODEINE PHOSPHATE 15 MG
|
86P-0200/CP
MIKART
|
CAPSULE OR TABLET |
Withdrawn |
3/26/2007 |
FLOXURIDINE 500 MG/5 ML
|
86P-0242/CP
QUAD
|
INJECTION |
Withdrawn |
3/26/2007 |
LORAZEPAM 1 MG/5 ML
|
86P-0292/CP
ROXANE
|
ORAL SOLUTION |
Withdrawn |
3/26/2007 |
ASPIRIN 356.4MG
CAFFEINE 30 MG
|
86P-0359/CP
CENTRAL PHARMS
|
TABLET |
Withdrawn |
3/26/2007 |
ACETAMINOPHEN 325 MG
ASPIRIN 325 MG
|
86P-0361/CP
BOCK PHARMA
|
TABLET |
Withdrawn |
3/26/2007 |
HYDROCHLOROTHIAZIDE 50 MG
TRIAMTERENE 75 MG
|
86P-0427/CP
PAR
|
CAPSULE |
Withdrawn |
3/26/2007 |
CHOLESTYRAMINE 500 MG
|
86P-0474/CP
BRISTOL MYERS
|
CAPSULE |
Withdrawn |
3/26/2007 |
FLUOCINONIDE 0.05%
|
87P-0004/CP
HAMER
|
LOTION |
Withdrawn |
3/26/2007 |
LORAZEPAM 0.5 MG, 1 MG, 2 MG
|
87P-0037/CP
APPLIED LABS
|
SOFT GELATIN CAPSULE |
Withdrawn |
3/26/2007 |
VERAPAMIL HYDROCHLORIDE 40MG/5ML OR 80MG/5ML
|
87P-0101/CP
MY-K
|
ORAL SOLUTION |
Withdrawn |
3/26/2007 |
VERAPAMIL HYDROCHLORIDE 120 MG OR 240 MG
|
87P-0233/CP
SEARLE
|
EXTENDED-RELEASE CAPSULE |
Withdrawn |
3/26/2007 |
IBUPROFEN 800 MG
|
87P-0242/CP
SIDMAK
|
SOFT GELATIN CAPSULE |
Withdrawn |
3/26/2007 |
DEXBROMPHENIRAMINE MALEATE 6 MG
PHENYLPROPANOLAMINE HYDROCHLORIDE 75 MG
|
87P-0265/CP
BOCK PHARMA
|
CONTROLLED-RELEASE TABLET |
Withdrawn |
3/26/2007 |
LOPERAMIDE HYDROCHLORIDE 2 MG
|
87P-0268/CP
KROSS
|
TABLET |
Withdrawn |
3/26/2007 |
CHOLESTYRAMINE RESIN 4 G
|
87P-0301/CP
CIBA
|
GEL |
Approved |
3/26/2007 |
CLEMASTINE FUMARATE 1.34 MG
PSEUDOEPHEDRINE HYDROCHLORIDE 120 MG
|
87P-0314/CP
SANDOZ
|
CONTROLLED-RELEASE TABLET |
Withdrawn |
3/26/2007 |
CHLORZOXAZONE 500 MG
|
82N-0032/CP6
MIKART
|
CAPSULE |
Withdrawn |
3/26/2007 |
ACETAMINOPHEN 160 MG/5ML
CODEINE PHOSPHATE 6 MG/5 ML
|
87P-0323/CP
KLEINFELD, KAPLAN & BECKER
|
SYRUP |
Withdrawn |
3/26/2007 |
TRIAMTERENE 50 MG
HYDROCHLOROTHIAZIDE 25 MG
|
87P-0335/CP
PAR
|
TABLET |
Withdrawn |
3/26/2007 |
NIFEDIPINE 10 MG OR 20 MG
|
87P-0340/CP
PAR
|
TABLET |
Withdrawn |
3/26/2007 |
PHENYTOIN SODIUM 100 MG; 250 MG/VIAL
|
87P-0367/CP
LYPHOMED
|
FOR INJECTION |
Withdrawn |
3/26/2007 |
PROPRANOLOL HYDROCHLORIDE 40 MG 0R 80 MG/5 ML
HYDROCHLOROTHIAZIDE 25 MG/5 ML
|
87P-0399/CP
BURDITT, BOWLES, ET. AL.
|
ORAL SOLUTION |
Withdrawn |
3/26/2007 |
CYCLOPHOSPHAMIDE 20 MG/ML, 500 ML,PBP
|
88P-0011/CP
BAXTER
|
INJECTION |
Withdrawn |
3/26/2007 |
CHLORHEXIDINE GLUCONATE 0.5%
|
88P-0036/CP
ARENT, FOX, ET. AL
|
SPRAY |
Withdrawn |
3/26/2007 |
HOMATROPINE METHYLBROMIDE 1.5 MG
HYDROCODONE BITARTRATE 5 MG
|
88P-0061/CP
KLEINFELD, KAPLAN & BECKER
|
SOFT GELATIN CAPSULE |
Withdrawn |
3/26/2007 |
LEUCOVORIN CALCIUM 1 MG/ML
|
88P-0149/CP
ROXANE
|
ORAL SOLUTION |
Withdrawn |
3/26/2007 |
QUINIDINE SULFATE 300 MG
|
88P-0277/CP
ROBINS AH
|
EXTENDED-RELEASE CAPSULE |
Withdrawn |
3/26/2007 |
CLEMASTINE FUMARATE 1.34 MG
PHENYLPROPANOLAMINE HYDROCHLORIDE 75 MG
|
88P-0350/CP
SCI CONSULTING
|
EXTENDED-RELEASE CAPSULE |
Withdrawn |
3/26/2007 |
CYCLOPHOSPHAMIDE 20 MG/ML, 250 ML PBP
|
88P-0379/CP
BAXTER
|
INJECTION |
Withdrawn |
3/26/2007 |
PREDNISONE 1,2.5,5,10,20,25,50
|
88P-0391/CP
ASCHER
|
CAPSULE |
Withdrawn |
3/26/2007 |
HYDROCORTISONE VALERATE 0.2%
|
89P-0028/CP
MCKENNA, CONNER, ET AL
|
LOTION |
Withdrawn |
3/26/2007 |
HYDROCORTISONE VALERATE 0.2%
|
89P-0029/CP
MCKENNA, CONNER, ET AL
|
TOPICAL SOLUTION |
Withdrawn |
3/26/2007 |
MORPHINE SULFATE 30 MG
|
89P-0071/CP
OXFORD RES INTL
|
EXTENDED-RELEASE CAPSULE |
Withdrawn |
3/26/2007 |
CARBAMAZEPINE 200 MG/5 ML
|
89P-0399/CP
GUIDELINES
|
ORAL SUSPENSION |
Withdrawn |
3/26/2007 |
PENTAMIDINE ISETHIONATE 100 MG/ML
|
89P-0435/CP
ASTRA
|
INJECTION |
Withdrawn |
3/26/2007 |
HYDROCORTISONE ACETATE 2.5% OR 1%
|
90P-0049/CP
FERNDALE
|
CREAM OR LOTION |
Withdrawn |
3/26/2007 |
CHLORZOXAZONE 250 MG
|
90P-0084/CP1
MIKART
|
CAPSULE |
Withdrawn |
3/26/2007 |
HYDROCORTISONE ACETATE 1%
|
90P-0154/CP
FERNDALE
|
OINTMENT |
Withdrawn |
3/26/2007 |
CLOBETASOL PROPIONATE 0.05%
RLD = TEMOVATE
|
90P-0198/CP
KROSS
|
LOTION |
Withdrawn |
3/26/2007 |
NIFEDIPINE 30 MG, 60 MG, 90 MG
|
90P-0436/CP1
KV
|
EXTENDED-RELEASE CAPSULE |
Withdrawn |
3/26/2007 |
ALBUTEROL SULFATE 4 MG
|
91P-0348/CP1
HAMER
|
CAPSULE; ETENDED-RELEASE |
Withdrawn |
3/26/2007 |
TRIAZOLAM 0.125 MG/5 ML
|
92P-0048/CP2
ROXANE
|
ORAL SOLUTION |
Withdrawn |
3/26/2007 |
HYDROCORTISONE ACETATE 2.5%
|
92P-0101/CP
HOGAN & HARTSON
|
AEROSOL |
Withdrawn |
3/26/2007 |
ACETAMINOPHEN 150 MG
ASPIRIN 180 MG
|
92P-0282/CP1
MIKART
|
CAPSULE OR TABLET |
Withdrawn |
3/26/2007 |
ACETAMINOPHEN 150 MG
ASPIRIN 180 MG
|
92P-0282/CP2
MIKART
|
CAPSULE OR TABLET |
Withdrawn |
3/26/2007 |
ACETAMINOPHEN 150 MG
ASPIRIN 180 MG
|
92P-0282/CP3
MIKART
|
CAPSULE OR TABLET |
Withdrawn |
3/26/2007 |
ACETAMINOPHEN 150 MG
ASPIRIN 180 MG
|
92P-0282/CP4
MIKART
|
CAPSULE OR TABLET |
Withdrawn |
3/26/2007 |
PROPRANOLOL HYDROCHLORIDE 40 MG
|
92P-0232/CP1
FLEMINGTON
|
EFFERVESCENT TABLET |
Withdrawn |
3/26/2007 |
ALBUTEROL SULFATE 2 MG, AND
4 MG
|
92P-0335/CP1
WE PHARMS
|
CHEWABLE TABLET |
Withdrawn |
3/26/2007 |
PREDNISONE 5 MG OR 10 MG
|
92P-0336/CP1
WE PHARMS
|
CHEWABLE TABLET |
Withdrawn |
3/26/2007 |
CYTARABINE 20 MG/ML, 12.5 ML
|
92P-0381/CP1
BRISTOL-MYERS SQUIBB
|
INJECTION |
Withdrawn |
3/26/2007 |
TRIMETHOPRIM 25 MG/5 ML
|
92P-0500/CP1
ASCENT PHARMS
|
ORAL SOLUTION |
Withdrawn |
3/26/2007 |
ACETAMINOPHEN 500 MG
CODEINE PHOSPHATE 45 MG
|
93P-0314/CP1
MIKART
|
CAPSULE OR TABLET |
Withdrawn |
3/26/2007 |
CIMETIDINE 200,300,400 OR 800MG
|
93P-0048/CP1
FLEMINGTON
|
EFFERVESCENT TABLET |
Withdrawn |
3/26/2007 |
PROPRANOLOL HYDROCHLORIDE 10, 20, 60, 80, 90MG
|
93P-0049/CP1
FLEMINGTON
|
EFFERVESCENT TABLET |
Withdrawn |
3/26/2007 |
ACETAMINOPHEN 325 MG
BUTALBITAL 50 MG
|
93P-0346/CP1
MIKART
|
CAPSULE OR TABLET |
Withdrawn |
3/26/2007 |
LOPERAMIDE HYDROCHLORIDE 1 MG
|
93P-0332/CP1
ELLIS PHARM
|
EFFERVESCENT TABLET |
Withdrawn |
3/26/2007 |
PREDNISONE 1,2.5,20,50 MG
|
93P-0333/CP1
DURA PHARMS
|
CHEWABLE TABLET |
Withdrawn |
3/26/2007 |
TERFENADINE 60 MG
PSEUDOEPHEDRINE 120 MG
|
93P-0367/CP1
EURAND AMERICA
|
EXTENDED-RELEASE CAPSULE |
Withdrawn |
3/26/2007 |
MORPHINE SULFATE 15MG,60MG,90MG,100MG
|
93P-0446/CP1
ETHYPHARM
|
EXTENDED-RELEASE CAPSULE |
Withdrawn |
3/26/2007 |
METHYLTESTOSTERONE 25 MG
|
93P-0459/CP1
ICN
|
CAPSULE |
Withdrawn |
3/26/2007 |
ACETAMINOPHEN 120 MG
CODEINE PHOSPHATE 12 MG
|
94P-0182/CP1
WE PHARMS
|
CHEWABLE TABLET |
Withdrawn |
3/26/2007 |
SULFAMETHOXAZOLE 200 MG
TRIMETHOPRIM 40 MG
|
94P-0186/CP1
DURA
|
CHEWABLE TABLET |
Withdrawn |
3/26/2007 |
ACETAMINOPHEN 150 MG
ASPIRIN 180 MG
|
94P-0210/CP1
MIKART
|
TABLET |
Withdrawn |
3/26/2007 |
ACETAMINOPHEN 150 MG
ASPIRIN 180 MG
|
94P-0211/CP1
MIKART
|
TABLET |
Withdrawn |
3/26/2007 |
ACETAMINOPHEN 150 MG
ASPIRIN 180 MG
|
94P-0212/CP1
MIKART
|
TABLET |
Withdrawn |
3/26/2007 |
FLUOROURACIL 5%
|
94P-0263/CP1
BRADLEY PHARMS
|
TOPICAL GEL |
Withdrawn |
3/26/2007 |
LEUCOVORIN CALCIUM 10 MG/ML 5 ML VIAL
|
94P-0433/CP2
LEDERLE LABORATORIES
|
INJECTABLE; INJECTION |
Withdrawn |
3/26/2007 |
METHYLPREDNISOLONE 16 MG
24 MG
|
94P-0432/CP1
DURA PHARMACEUTICALS
|
TABLET; CHEWABLE |
Withdrawn |
3/26/2007 |
LEUCOVORIN CALCIUM 10 MG/ML 350 MG VIAL
|
94P-0433/CP1
LEDERLE LABORATORIES
|
INJECTABLE; INJECTION |
Withdrawn |
3/26/2007 |
CAPTOPRIL 25 MG/ML
|
95P-0008/CP1
ROXANE LABS, INC.
|
ORAL SOLUTION |
Withdrawn |
3/26/2007 |
CARBIDOPA/LEVODOPA 25/100 MG
25/250 MG
|
95P-0100/CP1
ATHENA NEUROSCIENCES, INC.
|
POWDER FOR ORAL SOLUTION |
Withdrawn |
3/26/2007 |
HYDROCORTISONE BUTYRATE 0.1%
|
95P-0223/CP1
MCKENNA & CUNEO, L.L.P.
|
LOTION; TOPICAL |
Withdrawn |
3/26/2007 |
ACYCLOVIR SODIUM 5 MG/ML
|
95P-0268/CP1
WILMER, CUTLER, PICKERING
|
READY TO USE INFUSION |
Withdrawn |
3/26/2007 |
CHOLESTYRAMINE 2 G
|
95P-0277/CP1
MAYRAND PHARMACEUTICALS, INC
|
TABLET; ORAL (CHEWABLE) |
Withdrawn |
3/26/2007 |
BUTALBITAL 50 MG
ACETAMINOPHEN 325 MG
|
95P-0279/CP1
MIKART
|
CAPSULES AND TABLETS |
Withdrawn |
3/26/2007 |
BUTALBITAL 50 MG
ACETAMINOPHEN 325 MG
|
95P-0279/CP2
MIKART
|
CAPSULES AND TABLETS |
Withdrawn |
3/26/2007 |
BUTALBITAL 50 MG
ACETAMINOPHEN 500 MG
|
95P-0279/CP3
MIKART
|
CAPSULES AND TABLETS |
Withdrawn |
3/26/2007 |
BUTALBITAL 50 MG
ACETAMINOPHEN 500 MG
|
95P-0279/CP4
MIKART
|
CAPSULES AND TABLETS |
Withdrawn |
3/26/2007 |
NIFEDIPINE 30 MG, 60 MG, 90 MG
|
95P-0326/CP1
KV PHARMACEUTICAL
|
CAPSULE, EXTENDED RELEASE; ORAL |
Withdrawn |
3/26/2007 |
METRONIDAZOLE 0.75%
|
95P-0328/CP1
RNB PHARMACEUTICAL COMPANY
|
LOTION; TOPICAL |
Withdrawn |
3/26/2007 |
TRIPELENNAMINE HYDROCHLORIDE 25 MG/5 ML
DEXTROMETHORPHAN HYDROBROMIDE 15 MG/5 ML
|
95P-0345/CP1
BOCK PHARMACEUTICAL COMPANY
|
SYRUP;ORAL |
Withdrawn |
3/23/2000 |
AZATADINE MALEATE 1 MG
PHENYLEPHRINE HYDROCHLORIDE 30 MG
|
95P-0351/CP1
BOCK PHARMACEUTICAL COMPANY
|
TABLET; ORAL |
Withdrawn |
3/23/2000 |
POTASSIUM CHLORIDE 20 mEq
|
96P-0018/CP1
KV PHARMACEUTICAL
|
EXTENDED-RELEASE CAPSULES |
Withdrawn |
3/26/2007 |
POTASSIUM CHLORIDE 10 mEq
|
96P-0054/CP1
KV PHARMACEUTICAL COMPANY
|
FOR ORAL SUSPENSION EXTENDED-RELEASE |
Withdrawn |
3/26/2007 |
ASPIRIN 650 MG
BUTALBITAL 50 MG
|
96P-0021/CP1
SAVAGE LABS
|
CAPSULES |
Withdrawn |
3/26/2007 |
PENTOXYFYLLINE 400 MG
|
96P-0079/CP1
KV PHARMACEUTICAL COMPANY
|
EXTENDED-RELEASE PACKET (MICROPARTICLE) |
Withdrawn |
3/26/2007 |
LACTULOSE 10 G, 20 G
|
96P-0155/CP1
BENNETT AND COMPANY
|
POWDER FOR ORAL SOLUTION (EFFERVESCENT) |
Withdrawn |
4/24/2000 |
ACYCLOVIR 5%
|
96P-0307/CP1
PITNEY, HARDIN, KIPP & SZUCH
|
CREAM; TOPICAL |
Withdrawn |
3/26/2007 |
HYDROCORTISONE ACETATE 90 MG
|
96P-0376/CP1
PITNEY, HARDIN, KIPP & SZUCH
|
SUPPOSITORY; RECTAL |
Withdrawn |
3/26/2007 |
DILTIAZEM HYDROCHLORIDE 120 MG 180 MG 240 MG
RLD=CARDIAZEM CD
|
96P-0510/CP1
LABOPHARM INC.
|
TABLETS;EXTENDED-RELEASE |
Withdrawn |
3/26/2007 |
PREDNISOLONE SODIUM PHOSPHATE 15 MG/5 ML
|
96P-0499/CP1
WE PHARMACEUTICALS, INC.
|
LIQUID; ORAL |
Withdrawn |
4/5/2000 |
PREDNISOLONE SODIUM PHOSPHATE 10 MG (BASE)
|
96P-0498/CP1
WE PHARMACEUTICALS, INC.
|
TABLET; CHEWABLE |
Withdrawn |
4/5/2000 |
MEFENAMIC ACID 250 MG
|
97P-0155/CP1
PITNEY, HARDIN, KIPP AND SZUCH
|
TABLET; ORAL |
Withdrawn |
3/26/2007 |
DILTIAZEM HYDROCHLORIDE 120 MG 180 MG 240 MG
RLD=DILACOR XR
|
97P-0192/CP1
LABOPHARM, INC.
|
TABLET; EXTENDED-RELEASE; ORAL |
Withdrawn |
3/26/2007 |
DILTIAZEM HYDROCHLORIDE 120 MG 180 MG 240 MG
RLD = TIAZAC
|
97P-0195/CP1
LABOPHARM INC
|
TABLET; EXTENDED-RELEASE; ORAL |
Withdrawn |
3/26/2007 |
MORPHINE SULFATE 200 MG
|
97P-0225/CP1
ETHYPHARM
|
CAPSULE, EXTENDED RELEASE; ORAL |
Approved |
4/14/2000 |
ALBUTEROL SULFATE 2 MG & 4 MG
|
97P-0387/CP1
RICHARD A. HAMER ASS., INC.
|
TABLET; SUBLINGUAL |
Withdrawn |
3/26/2007 |
FAMOTIDINE 10 MG
|
97P-0404/CP1
THOMAS BLAKE, R.PH
|
TABLET; ORAL; EFFERVESCENT |
Withdrawn |
3/26/2007 |
CLOBETASOL PROPIONATE 0.05%
RLD = TEMOVATE E
|
98P-0068/CP1
RICHARD HAMER ASSOCIATES, INC.
|
LOTION; TOPICAL |
Withdrawn |
3/26/2007 |
IFOSFAMIDE 50 MG/ML - 20ML&60ML
|
98P-0146/CP1
MITCHALL G. CLARK
|
INJECTABLE; INJECTION |
Withdrawn |
3/26/2007 |
DILTIAZEM HYDROCHLORIDE 125MG/5ML;250MG/10ML
|
98P-0189/CP1
BEDFORD LABORATORIES
|
INJECTION |
Withdrawn |
|
CAPTOPRIL 25 MG/5 ML
|
98P-0199/CP1
MIRAN CONSULTING, INC.
|
SOLUTION; ORAL |
Withdrawn |
3/26/2007 |
OMEPRAZOLE 10 MG, 20 MG
|
98P-0225/CP1
ANDRX PHARMACEUTICALS INC.
|
TABLET; DELAYED RELEASE; ORAL |
Denied |
9/16/1999 |
HYDROMORPHONE HYDROCHLORIDE 0.2 MG/ML - 30 ML
|
98P-0821/CP1
ABBOTT LABORATORIES
|
INJECTABLE; INJECTION |
Denied |
9/29/1999 |
ECONAZOLE NITRATE 1%
|
98P-0745/CP1
MIRAN CONSULTING, INC.
|
OINTMENT; TOPICAL |
Withdrawn |
3/26/2007 |
CYCLOSPORINE 25 MG; 50 MG; 100 MG
|
98P-0858/CP1
APOTEX CORP
|
TABLET; ORAL |
Approved |
9/16/1999 |
METHYLPREDNISOLONE 4 MG & 16 MG
|
98P-0911/CP1
RICHARD HAMER ASSOCIATES, INC.
|
TABLET; SUBLINGUAL |
Denied |
6/14/1999 |
ACETAMINOPHEN 325 MG ; 325 MG
OXYCODONE HYDROCHLORIDE 4.5 MG ; 2.25 MG
|
98P-1219/CP1
KING AND SPALDING
|
TABLET; ORAL |
Denied |
2/26/2001 |
AMIODARONE 400 MG
|
99P-0343/CP1
OLSON FRANK AND WEEDA
|
TABLET; ORAL |
Approved |
7/21/1999 |
KETOROLAC TROMETHAMINE 30 MG/ML - 5 ML
|
99P-0510/CP1
APOTEX CORP.
|
INJECTABLE; INJECTION |
Approved |
9/16/1999 |
LEVOCARNITINE 200 MG/ML - 12.5 ML
|
99P-0553/CP1
GENSIA SICOR PHARMACEUTICALS
|
INJECTABLE; INJECTION |
Approved |
9/16/1999 |
IBUPROFEN 200 MG
|
99P-0683/CP1
FPC CONSULTING INC.
|
TABLET; ORAL |
Withdrawn |
9/16/1999 |
OMEPRAZOLE 40 MG
|
99P-1087/CP1
ANDRX PHARMACEUTICALS, INC.
|
TABLET; DELAYED-RELEASE, ORAL |
Approved |
4/18/2000 |
ETHINYL ESTRADIOL 0.035 MG
NORETHINDRONE 0.4 MG
|
99P-1150/CP1
KIRKLAND & ELLIS
|
TABLET; CHEWABLE |
Approved |
4/14/2000 |
CLOZAPINE 200 MG
|
99P-1268/CP1
LACHMAN CONSULTANT SERVICES
|
TABLET; ORAL |
Approved |
2/17/2000 |
CLOZAPINE 12.5 MG
|
99P-1267/CP1
LACHMAN CONSULTANT SERVICES
|
TABLET;ORAL |
Approved |
2/17/2000 |
METHYLPHENIDATE HYDROCHLORIDE 2.5 MG
|
99P-1418/CP1
LACHMAN CONSULTANT SERVICES
|
TABLET; ORAL |
Denied |
2/29/2000 |
METHYLPHENIDATE HYDROCHLORIDE 5 MG & 10 MG
|
99P-1417/CP1
LACHMAN CONSULTANT SERVICES
|
TABLET; CHEWABLE |
Denied |
2/29/2000 |
METHYLPHENIDATE HYDROCHLORIDE 5 MG/5 ML
10 MG/5 ML
|
99P-1416/CP1
LACHMAN CONSULTANT SERVICES
|
SOLUTION; ORAL |
Denied |
2/29/2000 |
PAMIDRONATE DISODIUM 3 MG/ML, 10 ML
9 MG/ML, 10 ML
|
99P-1653/CP1
MITCHELL G. CLARK
|
INJECTION |
Withdrawn |
10/14/1999 |
ACETAMINOPHEN 650 MG
BUTALBITAL 50 MG
|
99P-1657/CP1
MIKART INC.
|
TABLET; ORAL, CAPSULE;ORAL |
Approved |
4/14/2000 |
METHOTREXATE DISODIUM 2.5 MG/ML
|
99P-2078/CP1
MCKENNA & CUNEO, L.L.P.
|
FOR ORAL SOLUTION |
Withdrawn |
10/18/1999 |
ACETAMINOPHEN 750 MG
BUTALBITAL 50 MG
|
99P-2150/CP1
MIKART INC.
|
TABLET; ORAL, CAPSULE;ORAL |
Approved |
4/14/2000 |
ACETAMINOPHEN 500 MG
BUTALBITAL 50 MG
|
99P-2149/CP1
MIKART INC.
|
TABLET; ORAL, CAPSULE;ORAL |
Denied |
4/14/2000 |
ACETAMINOPHEN 325 MG
PROPOXYPHENE NAPSYLATE 100 MG
|
99P-2247/CP1
MIKART INC.
|
TABLET; ORAL, CAPSULE;ORAL |
Denied |
3/2/2001 |
PAMIDRONATE DISODIUM 3mg/mL - 10 mL
6mg/mL - 10 mL
|
99P-2252/CP1
FAULDING PHARMACEUTICAL CO.
|
INJECTION |
Approved |
4/18/2000 |
ACETAMINOPHEN 500 MG/15 ML
OXYCODONE HYDROCHLORIDE 7.5 MG/15 ML
|
99P-2776/CP1
KING AND SPALDING
|
LIQUID; ORAL |
Denied |
6/13/2000 |
ACETAMINOPHEN 500 mg
OXYCODONE HYDROCHLORIDE 10 mg
|
99P-2798/CP1
KING AND SPALDING
|
TABLET; ORAL |
Approved |
6/13/2000 |
ACETAMINOPHEN 400 MG;400 MG:400MG
HYDROCODONE BITARTRATE 5MG;7.5 MG:10 MG
|
99P-4107/CP1
PHARMACEUTICAL ASSOCIATES, INC
|
LIQUID; ORAL |
Denied |
3/2/2001 |
METHOTREXATE SODIUM 2.5 MG/ML
|
99P-2078/CP2
MCKENNA & CUNEO, L.L.P.
|
FOR ORAL SOLUTION |
Withdrawn |
3/29/2000 |
ACETAMINOPHEN 50 MG
PROPOXYPHENE NAPSYLATE 500 MG
|
99P-4649/CP1
MIKART INC.
|
TABLET/CAPSULES; ORAL |
Denied |
3/1/2001 |
NALTREXONE HYDROCHLORIDE 25MG, 100MG & 150MG
|
99P-4775/CP1
LACHMAN CONSULTANT SERVICES
|
TABLET; ORAL |
Approved |
4/13/2000 |
CEFAZOLIN SODIUM, STERILE 100 G & 300 G
|
99P-4870/CP1
QUINN CONSULTING SERVICES
|
FOR INJECTION |
Approved |
4/12/2002 |
CEFUROXIME SODIUM, STERILE 75 G & 225 G
|
99P-4871/CP1
QUINN CONSULTING SERVICES
|
FOR INJECTION |
Approved |
4/12/2002 |
DOXYCYCLINE 50 MG AND 100 MG
|
99P-4958/CP1
LACHMAN CONSULTANT SERVICES
|
TABLET; ORAL |
Approved |
2/4/2000 |
OXYCODONE HYDROCHLORIDE 9.25 MG, AND 7.0 MG
OXYCODONE TEREPHTHALATE 0.85 MG, AND 0.57 MG
|
99P-5105/CP1
KING & SPALDING
|
TABLET; ORAL |
Denied |
5/7/2001 |
CEFACLOR 125 MG, 187 MG
250 MG, 375 MG
|
99P-5447/CP1
THE WEINBERG GROUP INC.
|
TABLET; CHEWABLE;ORAL |
Approved |
6/13/2000 |
CEFACLOR 125 MG, 375 MG
375 MG, 500 MG
|
99P-5448/CP1
THE WEINBERG GROUP INC.
|
TABLETS FOR ORAL SUSPENSION |
Approved |
6/13/2000 |
CEPHALEXIN 125MG,250MG,500MG
|
99P-5451/CP1
THE WEINBERG GROUP INC
|
TABLETS FOR ORAL SUSPENSION |
Approved |
6/13/2000 |
ACYCLOVIR 200 MG
|
99P-5452/CP1
THE WEINBERG GROUP INC
|
TABLETS FOR ORAL SUSPENSION |
Approved |
6/13/2000 |
ACYCLOVIR 400MG & 800 MG
|
99P-5453/CP1
THE WEINBERG GROUP INC.
|
TABLET; FOR ORAL SUSPENSION |
Approved |
6/13/2000 |
CEFADROXIL HEMIHYDRATE 125MG,250MG,500MG
|
99P-5449/CP1
THE WEINBERG GROUP INC.
|
TABLETS FOR ORAL SUSPENSION |
Approved |
6/13/2000 |
AMOXICILLIN 125MG,250MG,200MG
400MG,500MG,875MG
|
99P-5450/CP1
THE WEINBERG GROUP INC.
|
TABLETS FOR ORAL SUSPENSION |
Approved |
6/13/2000 |
PAMIDRONATE DISODIUM 3MG/ML - 10 ML VIALS
9MG/ML - 10 ML VIALS
|
00P-0091/CP1
MITCHALL G. CLARK
|
INJECTION |
Approved |
4/18/2000 |
THIOTEPA, STERILE 30 MG/VIAL
|
00P-0092/CP1
GENSIA SICOR
|
FOR INJECTION |
Approved |
6/14/2000 |
ALBUTEROL SULFATE 0.0417%
|
00P-0913/CP1
MCDERMOTT, WILL AND EMERY
|
SOLUTION; INHALATION |
Approved |
6/13/2000 |
CALCITONIN-SALMON 100 IU/ML-1ML VIALS
|
00P-1213/CP1
FERRING PHARMACEUTICALS
|
INJECTION |
Approved |
6/13/2000 |
ACETAMINOPHEN; 325 MG & 500MG/15 ML
HYDROCODONE BITARTRATE 10 MG/15 ML
|
00P-1243/CP1
PHARMACEUTICAL ASSOCIATES, INC
|
SOLUTION; ORAL |
Denied |
5/7/2001 |
NIZATIDINE 75 MG
|
00P-1245/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULE; ORAL |
Approved |
4/17/2001 |
ACETAMINOPHEN; 325mg and 325 mg
OXYCODONE HYDROCHLORIDE 7.5 mg and 10 mg
|
00P-1270/CP1
KING AND SPALDING
|
TABLET; ORAL |
Approved |
9/9/2000 |
ACETAMINOPHEN; 400mg per tab
OXYCODONE HYDROCHLORIDE 2.5mg;5mg;7.5mg;10mg
|
00P-1271/CP1
KING AND SPALDING
|
TABLET; ORAL |
Approved |
9/9/2000 |
PROPOFOL 100 MG/10 ML (1%)
|
00P-1289/CP1
GENSIA SICOR
|
INJECTION |
Approved |
9/9/2000 |
ACETAMINOPHEN; 325MG/10ML
HYDROCODONE BITARTRATE 10MG/10ML
|
00P-1291/CP1
PHARMACEUTICAL ASSOCIATES, INC
|
SOLUTION; ORAL |
Denied |
5/7/2001 |
METHIMAZOLE 15 MG AND 20 MG
|
00P-1308/CP1
LACHMAN CONSULTANT SERVICES
|
TABLET; ORAL |
Approved |
9/9/2000 |
ACETAMINOPHEN; 500 MG
PROPOXYPHENE NAPSYLATE 100 MG
|
00P-1324/CP1
MIKART
|
TABLETS AND/OR CAPSULES |
Denied |
4/30/2001 |
AMIODARONE HYDROCHLORIDE 900 MG/18 ML
|
00P-1352/CP1
GENSIA SICOR
|
INJECTION |
Approved |
1/16/2001 |
FLUOXETINE 40 MG
|
00P-1365/CP1
LACHMAN CONSULTANT SERVICES
|
TABLET; ORAL |
Approved |
1/12/2001 |
GABAPENTIN 100MG,300MG,400MG
|
00P-1419/CP1
LACHMAN CONSULTANT SERVICES
|
TABLET; ORAL |
Approved |
1/12/2001 |
CEFACLOR 500 MG
|
00P-1397/CP1
THE WEINBERG GROUP INC.
|
TABLET; CHEWABLE |
Approved |
4/17/2001 |
ACETAMINOPHEN; 650 MG/ 30 ML
HYDROCODONE BITARTRATE 10 MG/30 ML
|
00P-1243/CP2
PHARMACEUTICAL ASSOCIATES INC.
|
SOLUTION; ORAL |
Denied |
5/7/2001 |
FAMOTIDINE 10MG
|
00P-1422/CP1
YAMANOUCHI PHARMA TECHNOLOGIES
|
TABLET; ORALLY DISINTEGRATING |
Approved |
4/17/2001 |
ACETAMINOPHEN; 650MG/30 ML
HYDROCODONE BITARTRATE 10MG/30ML
|
00P-1431/CP1
PHARMACEUTICAL ASSOCIATES INC
|
SOLUTION; ORAL |
Withdrawn |
9/6/2000 |
IOPAMIDOL
|
00P-1452/CP1
COOK IMAGING CORP.
|
INJECTION |
Approved |
4/23/2001 |
PHENYTOIN SODIUM 200 MG, 300 MG
|
00P-1462/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULE, EXTENDED RELEASE; ORAL |
Approved |
2/13/2000 |
SERTRALINE HYDROCHLORIDE 25MG, 50MG, 100MG
|
00P-1468/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULE; ORAL |
Approved |
7/3/2002 |
PROPOFOL 2%:20MG/ML:10ML,50ML
|
00P-1471/CP1
GENSIA SICOR PHARMACEUTICALS
|
INJECTION |
Denied |
4/30/2001 |
AMINO ACIDS 10% 1000mL & 2000mL
|
00P-1470/CP1
BAXTER HEALTHCARE CORP
|
INJECTION |
Approved |
1/11/2001 |
LEUCOVORIN CALCIUM 5 MG/ML - 100ML VIAL
|
00P-1518/CP1
PD REGULATORY SERVICES
|
INJECTION |
Withdrawn |
2/14/2001 |
PROPOXYPHENE NAPSYLATE; 50 MG
ACETAMINOPHEN 500 MG
|
00P-1551/CP1
ARNALL, GOLDEN & GREGORY
|
TABLET; ORAL |
Approved |
1/16/2001 |
PROPOXYPHENE NAPSYLATE; 100 MG
ACETAMINOPHEN 500 MG
|
00P-1551/CP2
ARNALL, GOLDEN & GREGORY
|
TABLET; ORAL |
Approved |
1/16/2001 |
URSODIOL 100 MG/5 ML
|
00P-1568/CP1
LACHMAN CONSULTANT SERVICES
|
SUSPENSION; ORAL |
Denied |
7/9/2002 |
POTASSIUM IODIDE 65 MG
|
00P-1574/CP1
R&R REGISTRATIONS
|
TABLET; ORAL |
Approved |
7/25/2001 |
CLADRIBINE 2 MG/ML - 5 ML VIAL
|
00P-1621/CP1
LIPOMED, INC.
|
INJECTION |
Denied |
8/1/2001 |
HYDROCODONE BITARTRATE; 10 MG/15 ML
ACETAMINOPHEN 325 MG/15ML
|
00P-1641/CP1
PHARMACEUTICAL ASSOCIATES INC.
|
SOLUTION; ORAL |
Approved |
4/17/2001 |
MERCAPTOPURINE 100 MG
|
00P-1645/CP1
McKENNA & CUNEO
|
TABLET; ORAL |
Approved |
4/17/2001 |
CARBAMAZEPINE 200 MG
|
01P-0028/CP1
TARO RESEARCH INSTITUTE LTD.
|
TABLET; CHEWABLE |
Approved |
5/8/2001 |
CARBOPLATIN 50 MG/5 ML ;10MG/ML
150 MG/15 ML;10MG/ML
|
01P-0036/CP1
VENABLE
|
INJECTION |
Approved |
11/30/2001 |
MIDODRINE HYDROCHLORIDE 15 MG
|
01P-0081/CP1
LACHMAN CONSULTANT SERVICES
|
TABLET; ORAL |
Approved |
5/8/2001 |
HYDROCORTISONE ACETATE 2%
|
01P-0085/CP1
FERNDALE LABORATORIES INC.
|
CREAM; TOPICAL |
Approved |
8/1/2001 |
DOXYCYCLINE 75 MG
|
01P-0109/CP1
THE WEINBERG GROUP INC.
|
CAPSULE; ORAL |
Approved |
8/2/2001 |
POTASSIUM CHLORIDE 15 mEq
|
01P-0108/CP1
LACHMAN CONSULTANTS
|
TABLET; EXTENDED-RELEASE; ORAL |
Approved |
7/9/2001 |
AMIODARONE HYDROCHLORIDE 100 MG
|
01P-0125/CP1
OLSON, FRANK AND WEEDA, P.C.
|
TABLET; ORAL |
Approved |
8/2/2001 |
ACETAMINOPHEN; 650 MG/15 ML
HYDROCODONE BITARTRATE 10 MG/15 ML
|
01P-0130/CP1
PHARMACEUTICAL ASSOCIATES, INC
|
SOLUTION; ORAL |
Approved |
8/20/2001 |
MIDAZOLAM 5 MG/ML-10 ML VIALS
|
01P-0136/CP1
ABBOTT LABORATORIES
|
INJECTION |
Approved |
8/5/2002 |
ACETAMINOPHEN; 500 MG/15 ML
HYDOCODONE BITARTRATE 10 MG/15 ML
|
01P-0144/CP1
PHARMACEUTICAL ASSOCIATES INC.
|
SOLUTION; ORAL |
Approved |
8/20/2001 |
KETAMINE HYDROCHLORIDE 100 MG/ML-10ML VIALS
|
01P-0156/CP1
BIONICHE PHARMA GROUP
|
INJECTION |
Approved |
8/20/2001 |
PROPOXYPHENE NAPSYLATE; 100 mg
ACETAMINOPHEN 325 mg
|
01P-0186/CP1
ARNALL, GOLDEN & GREGORY
|
TABLET; ORAL |
Approved |
8/20/2001 |
ACETAMINOPHEN; 320 MG/10 ML
HYDROCODONE BITARTRATE 10 MG/10 ML
|
01P-0130/CP2
PHARMACEUTICAL ASSOCIATES, INC
|
SOLUTION; ORAL |
Denied |
7/9/2002 |
PROGESTERONE 100 MG & 200 MG
|
01P-0209/CP1
DURAMED
|
TABLET; ORAL |
Approved |
7/3/2002 |
ACETAMINOPHEN; 325 MG/15 ML
HYDROCODONE BITARTRATE 7.5 MG/15 ML
|
01P-0214/CP1
PHARMACEUTICAL ASSOCIATES
|
SOLUTION; ORAL |
Approved |
8/20/2001 |
FLUOXETINE 20 MG & 40 MG
|
01P-0243/CP1
CIPHER PHARMACEUTICALS LTD.
|
CAPSULE; ORAL |
Withdrawn |
7/31/2001 |
SIMVASTATIN 10 MG & 40 MG
|
01P-0242/CP1
Cipher Pharmaceuticals, Ltd.
|
CAPSULE; ORAL |
Withdrawn |
7/31/2001 |
PAROXETINE 20 MG & 40 MG
|
01P-0241/CP1
CIPHER PHARMACEUTICALS LTD.
|
CAPSULE; ORAL |
Withdrawn |
2/12/2004 |
RAMIPRIL 2.5 MG & 10 MG
|
01P-0240/CP1
Cipher Pharmaceuticals Ltd.
|
CAPSULE; ORAL |
Withdrawn |
7/31/2001 |
AMLODIPINE 5 MG & 10 MG
|
01P-0239/CP1
CIPHER PHARMACEUTICALS LTD.
|
CAPSULE; ORAL |
Withdrawn |
2/12/2004 |
ACETAMINOPHEN; 500 MG
HYDROCODONE BITARTRATE 10 MG
|
01P-0251/CP1
MALLINKRODT
|
SOLUTION; ORAL |
Withdrawn |
8/23/2001 |
PENTOXIFYLLINE 500 MG
|
01P-0283/CP1
THE WEINBERG GROUP, INC.
|
TABLET; EXTENDED-RELEASE; ORAL |
Denied |
7/3/2002 |
LIDOCAINE 5%
|
01P-0291/CP1
Ferndale Laboratories Inc.
|
CREAM; TOPICAL |
Denied |
7/3/2002 |
TESTOSTERONE 5%
|
01P-0302/CP1
Testocream LLC
|
GEL; TOPICAL |
Denied |
4/12/2002 |
FLUOROURACIL 2.5%
|
01P-0288/CP1
Ferndale Laboratories Inc.
|
SOLUTION; TOPICAL |
Approved |
1/8/2002 |
SODIUM TETRADECYL SULFATE 0.5% & 0.2%
|
01P-0351/CP1
Bennett and Company
|
INJECTION |
Denied |
4/12/2002 |
HYDROCORTISONE ACETATE 2.5%
|
01P-0355/CP1
FERNDALE LABORATORIES INC
|
SUSPENSION; TOPICAL |
Pending |
|
HYDROCODONE BITARTRATE 7.5 MG/15ML
ACETAMINOPHEN 325MG/15ML
|
01P-0374/CP1
LACHMAN CONSULTANT SERVICES
|
SOLUTION; ORAL |
Withdrawn |
1/7/2002 |
METHADONE HYDROCHLORIDE 15MG,20MG,30MG,40MG
|
01P-0377/CP1
LACHMAN CONSULTANT SERVICES IN
|
TABLET; ORAL |
Withdrawn |
11/11/2002 |
AZATHIOPRINE 75 MG & 100 MG
|
01P-0379/CP1
AAI INTERNATIONAL
|
TABLET; ORAL |
Approved |
12/17/2001 |
CARBIDOPA; 10MG & 25MG & 25MG
LEVODOPA 100MG & 100MG &250MG
|
01P-0358/CP1
THE WEINBERG GROUP, INC.
|
TABLET FOR ORAL SUSPENSION |
Approved |
8/9/2002 |
PROPOFOL 2000MG/200 ML
|
01P-0430/CP1
GENSIA SICOR
|
INJECTABLE EMULSION |
Pending |
|
GANCICLOVIR SODIUM 500 MG/10 ML
|
01P-0440/CP1
BEN VENUE LAOBRATORIES, INC.
|
INJECTION |
Pending |
2/3/2004 |
HYDROCODONE BITARTRATE 10 MG
IBUPROFEN 200 MG
|
01P-0442/CP1
LACHMAN CONSULTANT SERVICES
|
TABLET; ORAL |
Approved |
12/20/2001 |
AMIODARONE 100 MG
|
01P-0445/CP1
TARO
|
TABLET; ORAL |
Withdrawn |
10/16/2001 |
HYDROCODONE BITARTRATE 10 MG
ACETAMINOPHEN 300 MG
|
01P-0441/CP1
LACHMAN CONSULTANT SERVICES
|
TABLET; ORAL |
Approved |
12/20/2001 |
DIGOXIN 0.05 MG/ML
|
01P-0449/CP1
ROXANE LABORATORIES INC.
|
SOLUTION; ORAL |
Withdrawn |
12/20/2001 |
ONDANSETRON HYDROCHLORIDE 16 MG
|
01P-0492/CP1
MCDERMOTT, WILL & EMERY
|
TABLET; ORAL |
Approved |
4/12/2002 |
HYDROCODONE BITARTRATE 10 MG, 7.5 MG
ACETAMINOPHEN 400 MG, 400 MG
|
01P-0504/CP1
SHOTWELL & CARR, INC.
|
TABLET; ORAL |
Withdrawn |
1/2/2002 |
DOXYCYCLINE 75 MG
|
01P-0515/CP1
LACHMAN CONSULTANT SERVICES
|
TABLET; ORAL |
Approved |
4/12/2002 |
HYDROCORTISONE ACETATE 2.5%
|
01P-0511/CP1
FERNDALE LABORATORIES, INC.
|
LOTION; TOPICAL |
Pending |
2/3/2004 |
DOXYCYCLINE 150 MG
|
01P-0516/CP1
LACHMAN CONSULTANT SERVICES
|
TABLET; ORAL |
Approved |
4/12/2002 |
HYDROCODONE BITARTRATE 7.5 MG & 10 MG
ACETAMINOPHEN 250 MG & 250 MG
|
01P-0521/CP1
SHOTWELL & CARR, INC.
|
TABLET; ORAL |
Denied |
7/3/2002 |
HYDROCODONE BITARTRATE 10 MG/15 ML
ACETAMINOPHEN 300 MG/15 ML
|
01P-0524/CP1
LACHMAN CONSULTANT SERVICES
|
SOLUTION; ORAL |
Approved |
8/6/2002 |
CARISOPRODOL 200 MG
|
01P-0526/CP1
ATLEY PHARMACEUTICALS, INC.
|
TABLET; ORAL |
Denied |
7/3/2002 |
ACETAMINOPHEN 200MG;200MG; 200MG
HYDROCODONE BITARTRATE 5MG;7.5MG;10MG
|
02P-0004/CP1
SHOTWELL AND CARR, INC.
|
TABLET; ORAL |
Denied |
3/17/2003 |
CARBIDOPA 25 MG; 10 MG; 25 MG
LEVODOPA 100MG; 100MG; 250MG
|
02P-0033/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS; ORALLY DISINTEGRATING |
Approved |
9/25/2002 |
BUTALBITAL 25 MG, 50 MG
ACETAMINOPHEN 300 MG, 600 MG
|
02P-0056/CP1
SHOTWELL & CARR, INC.
|
TABLET; ORAL |
Approved |
2/28/2003 |
BACLOFEN 10 mg, 20 mg
|
02P-0078/CP1
KLEINFELD, KAPLAN & BECKER
|
ORALLY DISINTEGRATING TABLETS |
Approved |
2/3/2004 |
OXYCODONE 5mg, 7.5mg, 10mg
ACETAMINOPHEN 300mg
|
02P-0105/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Approved |
8/6/2002 |
CARISOPRODOL 350 mg
|
02P-0138/CP1
LACHMAN CONSULTANT SERVICES
|
ORALLY DISINTEGRATING TABLETS |
Withdrawn |
7/25/2002 |
ESTROPIPATE 1.2 mg
|
02P-0141/CP1
WOMEN FIRST HEALTHCARE
|
TABLETS |
Approved |
9/24/2002 |
FENOFIBRATE 107 mg
|
02P-0148/CP1
LAVENDER CONSULTING SERVICES
|
TABLETS |
Approved |
9/25/2002 |
ISOTRETINOIN 30 mg
|
02P-0161/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULES |
Approved |
8/8/2002 |
LEVORPHANOL TARTRATE 1 mg, 3 mg
|
02P-0225/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Approved |
10/16/2002 |
METHOTREXATE SODIUM 5 mg/mL
|
02P-0226/CP1
KIRKPATRICK & LOCKHART LLP
|
ORAL SOLUTION |
Approved |
2/3/2004 |
HYDROCODONE BITARTRATE 5 mg
ACETAMINOPHEN 500 mg
|
02P-0233/CP1
KLEINFELD, KAPLAN AND BECKER
|
ORALLY DISINTEGRATING TABLETS |
Approved |
2/11/2004 |
FLUDARABINE PHOSPHATE 25 mg/mL
|
02P-0245/CP1
GENSIA SICOR PHARMACEUTICALS
|
SOLUTION FOR INJECTION |
Approved |
4/27/2004 |
MIRTAZAPINE 7.5 mg
|
02P-0249/CP1
AAC CONSULTING GROUP
|
TABLETS |
Approved |
2/27/2003 |
CLOZAPINE 50 mg
|
02P-0247/CP1
AAC CONSULTING GROUP
|
TABLETS |
Approved |
11/26/2002 |
HYDROCODONE BITARTRATE 5 mg
IBUPROFEN 200 mg
|
02P-0270/CP1
SCIREGS CONSULTING
|
TABLETS |
Approved |
9/25/2002 |
OXYCODONE HYDROCHLORIDE 15 mg, 20 mg
ACETAMINOPHEN 325 mg
|
02P-0285/CP1
KING & SPALDING
|
TABLETS |
Denied |
2/12/2003 |
PROPOXYPHENE HYDROCHLORIDE 65 mg
ACETAMINOPHEN 389 mg
|
02P-0297/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULES |
Denied |
2/3/2004 |
AMIODARONE HYDROCHLORIDE 50 MG/ ML 9 ML VIALS
|
02P-0346/CP1
GENSIA SICOR
|
INJECTION |
Approved |
2/25/2003 |
AMOXICILLIN 300 mg, 600 mg
|
02P-0358/CP1
THE WEINBERG GROUP
|
TABLETS FOR ORAL SUSPENSION |
Approved |
11/26/2002 |
LOPERAMIDE HYDROCHLORIDE 1 MG
|
02P-0424/CP1
BANNER PHARMACAPS
|
CAPSULE; ORAL |
Approved |
2/3/2004 |
LOPERAMIDE HYDROCHLORIDE 2 mg
|
02P-0380/CP1
BANNER PHARMACAPS
|
SOFT GELATIN CAPSULES |
Pending |
2/3/2004 |
HYDROCODONE BITARTRATE 7.5 mg
IBUPROFEN 200 mg
|
02P-0386/CP1
PHARMACEUTICAL ASSOCIATES
|
ORAL SUSPENSION |
Pending |
2/3/2004 |
AMIODARONE HYDROCHLORIDE 300 mg
|
02P-0394/CP1
TARO RESEARCH INSTITUTE
|
TABLETS |
Approved |
3/6/2003 |
AMOXICILLIN 600mg
CLAVULANATE POTASSIUM 42.9mg
|
02P-0406/CP1
THE WEINBERG GROUP, INC.
|
TABLETS FOR ORAL SUSPENSION |
Denied |
10/15/2004 |
CEFUROXIME AXETIL 125mg and 250mg
|
02P-0414/CP1
THE WEINBERG GROUP, INC
|
TABLETS FOR ORAL SUSPENSION |
Denied |
4/29/2004 |
PROPOXYPHENE NAPSYLATE 100 mg
ACETAMINOPHEN 325 mg, 500 mg
|
02P-0422/CP1
FROMMER LAWRENCE & HAUG
|
ORAL TABLETS |
Withdrawn |
3/7/2003 |
AMIODARONE HYDROCHLORIDE 50mg/mL, 18mL vial
|
02P-0419/CP1
BIONICHE PHARMA GROUP
|
INJECTION |
Withdrawn |
4/22/2003 |
RIBAVIRIN 200 MG
|
02P-0436/CP1
BIOPARTNERS
|
TABLET |
Pending |
2/3/2004 |
CEFPODOXIME PROXETIL 50 mg, 100 mg
|
02P-0444/CP1
THE WEINBERG GROUP
|
TABLETS FOR ORAL SUSPENSION |
Denied |
6/7/2005 |
ALBUTEROL SULFATE .083% (base)
|
02P-0448/CP1
SENSORMEDICS CORPORATION
|
INHALATION SOLUTION |
Denied |
12/17/2003 |
METOPROLOL TARTRATE 25 mg
|
02P-0460/CP1
CARACO PHARMACEUTICAL
|
TABLETS |
Approved |
2/13/2003 |
METOPROLOL TARTRATE 25 mg
|
02P-0459/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Approved |
2/13/2003 |
OXYCODONE HYDROCHLORIDE 2.5 mg
ACETAMINOPHEN 300 mg
|
02P-0465/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Approved |
2/13/2003 |
NAPROXEN SODIUM 220 mg
|
02P-0473/CP1
BANNER PHARMACAPS
|
SOFT GELATIN CAPSULES |
Withdrawn |
4/13/2005 |
FENTANYL 12.5 mcg/hr
|
02P-0478/CP1
LACHMAN CONSULTANT SERVICES
|
TRANSDERMAL SYSTEM |
Withdrawn |
10/14/2003 |
AMIODARONE HYDROCHLORIDE 450 mg/9 mL
|
02P-0480/CP1
BIONICHE PHARMA GROUP
|
INJECTION |
Approved |
2/25/2003 |
METHADONE HYDROCHLORIDE 15mg, 20mg, 30mg
|
02P-0481/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS (DISPERSIBLE) |
Approved |
3/4/2003 |
AMIODARONE HYDROCHLORIDE 300mg/6mL, 450mg/9mL
|
02P-0484/CP1
LACHMAN CONSULTANT SERVICES
|
INJECTION |
Approved |
2/25/2003 |
WARFARIN SODIUM 0.5 mg
|
02P-0498/CP1
TARO PHARMACEUTICALS
|
TABLETS |
Approved |
4/14/2003 |
METFORMIN HYDROCHLORIDE 500mg, 850mg, 1000mg
|
02P-0499/CP1
THE WEINBERG GROUP
|
TABLETS FOR ORAL SOLUTION |
Approved |
2/11/2004 |
DIGOXIN 0.25 MG/5 ML
|
02P-0503/CP1
ROXANE LABORATORIES
|
ELIXIR |
Withdrawn |
|
URSODIOL 20 MG/ML
|
03P-0082/CP1
LACHMAN CONSULTANT SERVICES
|
ORAL SUSPENSION |
Withdrawn |
2/3/2004 |
CARBAMAZEPINE 100mg, 300mg, 400mg
|
03P-0083/CP1
TARO PHARMACEUTICALS
|
TABLETS |
Approved |
12/17/2003 |
HYDROCODONE POLISTIREX 5 MG, 10 MG
CHLORPHENIRAMINE POLISTIREX 4 MG, 8 MG
|
03P-0091/CP1
LACHMAN CONSULTANT SERVICES
|
EXTENDED RELEASE CAPSULES |
Approved |
8/31/2004 |
OXYCODONE HYDROCHLORIDE 15 MG, 20 MG
ACETAMINOPHEN 325MG, 325 MG
|
02P-0285/PRC1
KING & SPALDING
|
TABLET; ORAL |
Denied |
7/30/2004 |
OXYCODONE HYDROCHLORIDE 15 MG, 20 MG
ACETAMINOPHEN 325 MG
|
02P-0285/PRC1
KING & SPALDING
|
TABLETS |
Denied |
7/30/2004 |
EPIRUBICIN HYDROCHLORIDE 10mg/ 5mL;150mg/75mL
|
03P-0110/CP1
FAULDING PHARMACEUTICAL CO.
|
INJECTION |
Approved |
8/13/2003 |
METHADONE HYDROCHLORIDE 15MG,20MG,30MG,40MG
|
03P-0119/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS USP |
Pending |
5/13/2003 |
VENLAFAXINE HYDROCHLORIDE 37.5MG, 75MG, 150MG
|
03P-0159/CP1
LACHMAN CONSULTANT SERVICES
|
EXTENDED RELEASE TABLETS |
Approved |
3/30/2005 |
DIVALPROEX SODIUM 1000 MG
|
03P-0178/CP1
LACHMAN CONSULTANT SERVICES
|
EXTENDED RELEASE TABLETS |
Approved |
8/18/2003 |
NAFCILLIN SODIUM 200 GRAM
|
03P-0184/CP1
SAMSON MEDICAL TECHNOLOGIES
|
INJECTION |
Approved |
8/18/2003 |
GLYBURIDE 1.25mg, 2.5mg, 5mg
METFORMIN HYDROCHLORIDE 250mg, 500mg, 500mg
|
03P-0188/CP1
THE WEINBERG GROUP
|
TABLETS FOR ORAL SOLUTION |
Approved |
7/30/2004 |
LEVONORGESTREL 1.5 MG
|
03P-0216/CP1
HRA PHARMA
|
TABLET |
Denied |
12/17/2003 |
CARBOPLATIN 600 MG/60 ML
|
03P-0220/CP1
FAULDING
|
INJECTION |
Denied |
2/3/2004 |
GLIPIZIDE 2.5 MG, 5 MG
METFORMIN HYDROCHLORIDE 250 MG, 500 MG
|
03P-0218/CP1
THE WEINBERG GROUP
|
TABLETS FOR ORAL SOLUTION |
Approved |
7/30/2004 |
CEFOXITIN 100 GRAM, 300 GRAM
|
03P-0227/CP1
SAMSON MEDICAL TECHNOLOGIES
|
INJECTION |
Approved |
10/1/2003 |
CLARITHROMYCIN 1000 MG
|
03P-0238/CP1
THE WEINBERG GROUP
|
EXTENDED-RELEASE TABLETS |
Approved |
12/18/2003 |
PROPRANOLOL HYDROCHLORIDE 60, 80, 120, 160 MG
|
03P-0237/CP1
URL MUTUAL
|
EXTENDED-RELEASE TABLETS |
Approved |
2/3/2004 |
FLUOCINOLONE ACETONIDE 0.01%
HYDROQUINONE 4%
|
03P-0279/CP1
JERUSSI CONSULTING
|
TOPICAL SOLUTION |
Denied |
4/1/2005 |
GLIMEPIRIDE 8 MG
|
03P-0283/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Approved |
10/6/2003 |
CEFTAZIDIME 100GM PHARM BULK PKG
|
03P-0292/CP1
SAMSON MEDICAL TECHNOLOGIES
|
INJECTION |
Pending |
|
DICLOFENAC POTASSIUM 25 MG
|
03P-0298/CP1
THE WEINBERG GROUP
|
CAPSULES |
Pending |
2/3/2004 |
WARFARIN SODIUM 1.5 MG
|
03P-0307/CP1
TARO PHARMACEUTICALS
|
TABLETS |
Approved |
10/6/2003 |
CARBAMAZEPINE 200 MG/5 ML
|
03P-0304/CP1
TARO PHARMACEUTICALS
|
ORAL SUSPENSION |
Pending |
|
HYDROCODONE BITARTRATE 5 MG, 7.5 MG, 10 MG
IBUPROFEN 400 MG
|
03P-0331/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Denied |
4/1/2005 |
HYDROQUINONE 4%
TRETINOIN 0.01%
|
03P-0365/CP1
JERUSSI CONSULTING
|
TOPICAL SOLUTION |
Denied |
12/2/2004 |
HYDROCODONE BITARTRATE 5 MG
BUTALBITAL 50 MG
|
03P-0398/CP1
INTN'L REGULATORY BUSINESS
|
CAPSULE |
Withdrawn |
|
METFORMIN HYDROCHLORIDE 1000 MG
|
03P-0388/CP1
LACHMAN CONSULTANT SERVICES
|
EXTENDED RELEASE TABLETS |
Approved |
12/23/2003 |
HYDROCODONE BITARTRATE 7.5 MG
ACETAMINOPHEN 300 MG
|
03P-0413/CP1
LACHMAN CONSULTANT SERVICES
|
TABLET |
Approved |
9/28/2004 |
HYDROCODONE BITARTRATE 5 MG
ACETAMINOPHEN 300 MG
|
03P-0414/CP1
LACHMAN CONSULTANT SERVICES
|
TABLET |
Approved |
11/23/2004 |
HYDROCODONE BITARTRATE 5 MG, 7.5MG & 10 MG
ACETAMINOPHEN 300 MG,300 MG&300 MG
|
03P-0436/CP1
ANABOLIC LABORATORIES, INC.
|
TABLET; ORAL |
Approved |
10/10/2003 |
METOPROLOL TARTRATE 12.5 MG
|
03P-0441/CP1
NABEAL M. SAIF
|
TABLETS |
Denied |
10/15/2004 |
KETOPROFEN; 12.5 MG
HYDROCODONE BITARTRATE 7.5 MG
|
03P-0453/CP1
KING & SPALDING LLP
|
TABLET |
Denied |
3/15/2006 |
CARISOPRODOL 200 MG
ACETAMINOPHEN 325 MG
|
03P-0460/CP1
ANABOLIC LABORATORIES, INC.
|
TABLET; ORAL |
Pending |
2/4/2004 |
CYCLOBENZAPRINE HYDROCHLORIDE 7.5 MG
|
03P-0461/CP1
ANABOLIC LABORATORIES
|
TABLET; ORAL |
Approved |
10/15/2004 |
CLONAZEPAM 1 MG/5 ML
|
03P-0464/CP1
LACHMAN CONSULTANT SERVICES
|
ORAL SUSPENSION |
Approved |
10/17/2005 |
HYDROCODONE BITARTRATE 5 MG
ACETAMINOPHEN 325 MG
|
03P-0475/CP1
INT'L REGULATORY BUSINESS CONS
|
LIQUID; ORAL |
Withdrawn |
2/4/2004 |
ACETAMINOPHEN 770 MG, 385 MG
CAFFEINE 60 MG, 30 MG
|
03P-0505/CP1
LACHMAN CONSULTANT SERVICES
|
TABLET |
Withdrawn |
10/19/2004 |
ONDANSETRON HYDROCHLORIDE 8, 12, 16, 20, 24MG
IN 50 ML 5% DEXTROSE
|
03P-0519/CP1
ABBOTT LABORATORIES
|
INJECTION |
Withdrawn |
4/12/2004 |
GLYBURIDE 1.25MG, 2.5MG, 5 MG
METFORMIN HYDROCHLORIDE 250MG, 500MG,
|
03P-0534/CP1
LACHMAN CONSULTANT SERVICES
|
ORAL SOLUTION |
Approved |
7/30/2004 |
CITALOPRAM HYDROBROMIDE 10 MG, 20 MG, 40 MG
|
03P-0551/CP1
FROMMER LAWRENCE & HAUG
|
CAPSULE |
Approved |
3/29/2005 |
DIHYDROERGOTAMINE MESYLATE 2 MG/ML
|
03P-0556/CP1
HYMAN, PHELPS & MCNAMARA
|
INJECTION |
Denied |
4/1/2005 |
ONDANSETRON HYDROCHLORIDE 8 MG/4 ML
|
04P-0048/CP1
ABBOTT LABORATORIES
|
INJECTION |
Withdrawn |
4/12/2004 |
DOXYCYCLINE HYCLATE 75 MG, 100 MG
|
04P-0054/CP1
URL MUTUAL
|
CAPSULES |
Withdrawn |
4/12/2004 |
ONDANSETRON 16 MG, 24 MG
|
04P-0056/CP1
LACHMAN CONSULTANT SERVICES
|
ORALLY DISINTEGRATING TABLETS |
Approved |
7/7/2004 |
FENTANYL 37.5 mcg/hr
62.5 mcg/hr
|
04P-0069/CP1
LACHMAN CONSULTANT SERVICES
|
TRANSDERMAL SYSTEM |
Approved |
7/7/2004 |
ESMOLOL HYDROCHLORIDE 2500 MG/VIAL
|
04P-0085/CP1
BEDFORD LABORATORIES
|
INJECTION |
Denied |
6/7/2005 |
POTASSIUM IODIDE 65 MG/ML
|
04P-0092/CP1
RRD INTERNATIONAL
|
ORAL SOLUTION |
Approved |
3/3/2004 |
GLIMEPIRIDE 3 MG, 6 MG
|
04P-0123/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Approved |
7/7/2004 |
SERTRALINE HYDROCHLORIDE 150 MG, 200 MG
|
04P-0125/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Withdrawn |
4/12/2004 |
TOBRAMYCIN 100 MG/ML
|
04P-0131/CP1
SOURCE CF
|
SOLUTION FOR INHALATION |
Pending |
3/29/2004 |
OXYCODONE HYDROCHLORIDE 5 MG, 10 MG, 20 MG
|
04P-0148/CP1
THE WEINBERG GROUP
|
TABLETS |
Approved |
9/28/2004 |
OXYCODONE HYDROCHLORIDE 2.5 MG, 5 MG
ACETAMINOPHEN 325 MG
|
04P-0149/CP1
ENDO PHARMACEUTICALS
|
ORALLY DISINTEGRATING TABLETS |
Withdrawn |
5/4/2006 |
OXYCODONE HYDROCHLORIDE 7.5 MG, 10.0 MG
ACETAMINOPHEN 325 MG
|
04P-0150/CP1
ENDO PHARMACEUTICALS
|
ORALLY DISINTEGRATING TABLETS |
Withdrawn |
5/4/2006 |
HYDROMORPHONE HYDROCHLORIDE 2 MG, 4 MG
|
04P-0152/CP1
THE WEINBERG GROUP
|
TABLETS |
Approved |
9/28/2004 |
OXYCODONE HYDROCHLORIDE 5, 10, 15, 20, 30 MG
|
04P-0153/CP1
THE WEINBERG GROUP
|
CAPSULES |
Denied |
5/17/2005 |
AMOXICILLIN 200 MG, 400 MG
CLAVULANATE POTASSIUM 28.5 MG, 57 MG
|
04P-0157/CP1
THE WEINBERG GROUP
|
TABLETS FOR ORAL SUSPENSION |
Approved |
9/28/2006 |
GLIPIZIDE 2.5 mg, 5 mg
METFORMIN HYDROCHLORIDE 250mg/5mL;500mg/10mL
|
04P-0168/CP1
LACHMAN CONSULTANT SERVICES
|
ORAL SOLUTION |
Approved |
11/23/2004 |
CEFPROZIL 125 MG, 250 MG
|
04P-0173/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS FOR ORAL SUSPENSION |
Denied |
6/7/2005 |
RIBAVIRIN 400 MG, 600 MG
|
04P-0196/CP1
FROMMER LAWRENCE & HAUG
|
TABLETS |
Approved |
9/28/2004 |
DIVALPROEX SODIUM 750 MG
|
04P-0195/CP1
LACHMAN CONSULTANT SERVICES
|
EXTENDED RELEASE TABLETS |
Approved |
9/28/2004 |
GLYBURIDE 1.25 MG, 2.5 MG, 5MG
METFORMIN HYDROCHLORIDE 250 MG, 500 MG
|
04P-0209/CP1
THE WEINBERG GROUP
|
TABLETS FOR ORAL SUSPENSION |
Approved |
11/23/2004 |
GLIPIZIDE 2.5 MG, 5 MG
METFORMIN HYDROCHLORIDE 250 MG, 500 MG
|
04P-0208/CP1
THE WEINBERG GROUP
|
TABLETS FOR ORAL SUSPENSION |
Approved |
11/23/2004 |
PRAVASTATIN SODIUM 30 MG
|
04P-0216/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Approved |
9/28/2004 |
DOXYCYCLINE 150 MG
|
04P-0219/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULES |
Approved |
9/28/2004 |
PRAVASTATIN SODIUM 60 MG
|
04P-0213/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Approved |
9/28/2004 |
CIPROFLOXACIN HYDROCHLORIDE 0.4 ML UNIT DOSE
|
04P-0222/CP1
STRADLING YOCCA CARLSON & RAUT
|
OPHTHALMIC SOLUTION |
Pending |
5/24/2004 |
OXYCODONE 2.5, 5, 7.5, 10 MG
ACETAMINOPHEN 400 MG
|
04P-0243/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Withdrawn |
6/10/2004 |
ESCITALOPRAM OXALATE 10 MG, 20 MG
|
04P-0247/CP1
FROMMER LAWRENCE & HAUG
|
CAPSULE |
Approved |
3/29/2005 |
HYDROCODONE BITARTRATE 5 MG, 7.5 MG, 10 MG
ACETAMINOPHEN 700 MG
|
04P-0252/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Approved |
10/17/2005 |
CEFIXIME 100MG, 150MG, 200MG
|
04P-0263/CP1
LUPIN PHARMACEUTICALS
|
CHEWABLE TABLETS |
Approved |
10/6/2005 |
NICOTINE BITARTRATE 2 MG/240 ML
4 MG/240 ML
|
04P-0282/CP1
NICO WORLDWIDE, LLC
|
ORAL SOLUTION |
Pending |
7/14/2004 |
NICOTINE POLACRILEX 2 MG/240 ML
4 MG/240 ML
|
04P-0280/CP1
NICO WORLDWIDE, LLC
|
ORAL SOLUTION |
Denied |
5/26/2005 |
NICOTINE BASE 2 MG/240 ML
4 MG/240 ML
|
04P-0281/CP1
NICO WORLDWIDE, LLC
|
ORAL SOLUTION |
Pending |
7/14/2004 |
BENZONATATE 150 MG
|
04P-0321/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULES |
Approved |
11/23/2004 |
ADENOSINE 18 MG/6 ML
30 MG/10 ML
|
04P-0326/CP1
APOTEX CORPORATION
|
INJECTION |
Denied |
8/22/2007 |
FAMOTIDINE 10 MG
|
04P-0353/CP1
LACHMAN CONSULTANT SERVICES
|
ORALLY DISSOLVING STRIPS |
Approved |
7/5/2005 |
METHACHOLINE CHLORIDE 1280 MG/VIAL
|
04P-0359/CP1
METHAPHARM
|
ORAL INHALATION |
Withdrawn |
3/21/2006 |
SODIUM FERRIC GLUCONATE 10 ML/125 MG
COMPLEX IN SUCROSE
|
04P-0360/CP1
AAC CONSULTING
|
INJECTION |
Approved |
3/15/2006 |
OMEPRAZOLE MAGNESIUM 20 MG BASE
|
04P-0373/CP1
GRAY CARY
|
DELAYED RELEASE CAPSULE |
Approved |
7/5/2005 |
DOXYCYCLINE HYCLATE 75 MG, 100 MG
|
04P-0390/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Pending |
9/21/2004 |
TRAMADOL HYDROCHLORIDE 50 MG PER 5 ML
|
04P-0405/CP1
LACHMAN CONSULTANT SERVICES
|
ORAL SOLUTION |
Denied |
7/28/2005 |
METOCLOPRAMIDE HYDROCHLORIDE 5 MG, 10 MG
|
04P-0409/CP1
LACHMAN CONSULTANT SERVICES
|
ORALLY DISINTEGRATING TABLETS |
Withdrawn |
10/17/2005 |
ATORVASTATIN CALCIUM 10MG/20MG/40MG/80MG
|
04P-0418/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULES |
Withdrawn |
7/1/2005 |
FLUCONAZOLE 100 MG/50 ML
|
04P-0434/CP1
BEN VENUE LABORATORIES
|
INJECTION |
Approved |
8/18/2006 |
CARBINOXAMINE MALEATE 4 MG
|
04P-0451/CP1
NUTEC INCORPORATED
|
CHEWABLE TABLET |
Pending |
10/8/2004 |
MEPERIDINE HYDROCHLORIDE 75 MG, 150 MG
|
04P-0500/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Approved |
3/31/2005 |
METHACHOLINE CHLORIDE 1280 MG/VIAL
|
04P-0511/CP1
ACIC FINE CHEMICALS, INC.
|
POWDER, METERED |
Withdrawn |
3/21/2006 |
SELEGILINE HYDROCHLORIDE 5 MG
|
04P-0514/CP1
LACHMAN CONSULTANT SERVICES
|
ORALLY DISINTEGRATING TABLETS |
Pending |
|
TERBUTALINE SULFATE 1 MG/ML
25 ML PHARMACY BULK
|
04P-0518/CP1
BEN VENUE
|
INJECTION |
Pending |
|
CHLORHEXIDINE GLUCONATE 2%
ISOPROPOL ALCOHOL 70%
|
04P-0528/CP1
CARDINAL HEALTH
|
SOLUTION; TOPICAL |
Pending |
12/6/2004 |
ONDANSETRON HYDROCHLORIDE 8 MG/4 ML
|
04P-0544/CP1
OLSSON, FRANK AND WEEDA
|
INJECTION |
Pending |
12/21/2004 |
ACETAMINOPHEN 300 MG
BUTALBITAL 50 MG
|
04P-0561/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULES |
Approved |
3/31/2005 |
ACETAMINOPHEN 300 MG
BUTALBITAL 50 MG
|
04P-0560/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULES |
Approved |
3/31/2005 |
BUMETANIDE 6.25 MG/25 ML
|
05P-0006/CP1
BEN VENUE LABORATORIES
|
INJECTION |
Pending |
1/18/2005 |
RISPERIDONE 0.25 MG
|
05P-0007/CP1
LACHMAN CONSULTANT SERVICES
|
ORALLY DISINTEGRATING TABLETS |
Approved |
3/31/2005 |
CEFIXIME 200 MG/5 ML
|
05P-0013/CP1
LUPIN PHARMACEUTICALS
|
ORAL SUSPENSION |
Approved |
4/8/2005 |
CHLORZOXAZONE 375 MG
|
05P-0044/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Approved |
4/8/2005 |
COLISTIMETHATE SODIUM 150 MG/2 ML
|
05P-0050/CP1
PRG CONSULTING
|
SOLUTION |
Approved |
10/17/2005 |
HYDROCHLOROTHIAZIDE 12.5 MG
|
05P-0060/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Approved |
4/8/2005 |
AMLODIPINE BESYLATE 2.5 MG, 5 MG, 10 MG
|
05P-0066/CP1
DLA PIPER RUDNICK GRAY CARY
|
CAPSULES |
Denied |
6/7/2006 |
CALCITONIN, SALMON 2500 IU/0.25 MG
|
05P-0070/CP1
LATHAM & WATKINS
|
TABLET OR CAPSULE |
Denied |
6/2/2006 |
CHLORHEXIDINE GLUCONATE 2%
ISOPROPYL ALCOHOL 70%
|
05P-0074/CP1
APLICARE INC.
|
TOPICAL SOLUTION |
Pending |
4/8/2005 |
PREDNISOLONE SODIUM PHOSPHATE 10MG/5ML; 20MG/5ML;
25MG/5ML
|
05P-0080/CP1
LACHMAN CONSULTANT SERVICES
|
SOLUTION |
Approved |
4/8/2005 |
EDETATE DISODIUM
|
05P-0085/CP1
MCGUFF PHARMACEUTICALS
|
INJECTION |
Pending |
2/23/2005 |
CEFTRIAXONE 100 GRAM
|
05P-0114/CP1
SAMSON MEDICAL TECHNOLOGIES
|
INJECTION |
Approved |
7/14/2005 |
OXYCODONE HYDROCHLORIDE 7.5 MG
|
05P-0140/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Approved |
7/14/2005 |
OXYCODONE HYDROCHLORIDE 20 MG/ML
|
05P-0144/CP1
THE WEINBERG GROUP
|
ORAL SOLUTION |
Denied |
3/28/2006 |
BACLOFEN 10 MG/5 ML
|
05P-0156/CP1
PHASE V PHARMACEUTICALS
|
ORAL SOLUTION |
Withdrawn |
7/18/2005 |
DIPHENOXYLATE HYDROCHLORIDE 5 MG
ATROPINE SULFATE 0.05 MG/5 ML
|
05P-0162/CP1
LACHMAN CONSULTANT SERVICES
|
ORAL SOLUTION |
Denied |
12/10/2008 |
DIPHENOXYLATE HYDROCHLORIDE 5 MG
ATROPINE SULFATE 0.05 MG
|
05P-0161/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Denied |
12/10/2008 |
VENLAFAXINE HYDROCHLORIDE 37.5MG, 75MG, 150MG
|
03P-0159/PRC1
COVINGTON & BURLING
|
TABLET; EXTENDED-RELEASE; ORAL |
Pending |
5/5/2005 |
VENLAFAXINE HYDROCHLORIDE 37.5MG, 75MG, 150MG
|
03P-0159/PSA1
COVINGTON & BURLING
|
TABLET; EXTENDED-RELEASE; ORAL |
Pending |
5/5/2005 |
CEFDITOREN PIVOXIL 400 MG
|
05P-0176/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Approved |
7/14/2005 |
RIBAVIRIN USP 500 MG
|
05P-0179/CP1
KILPATRICK STOCKTON
|
TABLETS |
Approved |
7/14/2005 |
HYDROCODONE BITARTRATE 2.5 MG
IBUPROFEN 200 MG
|
05P-0180/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Approved |
7/14/2005 |
LAMOTRIGINE 50 MG; 250 MG
|
05P-0212/CP1
PHARMACEUTICAL PATENT ATTORNEY
|
TABLETS |
Withdrawn |
7/1/2005 |
OXYCODONE HYDROCHLORIDE 30 MG, 60 MG
|
05P-0225/CP1
THE WEINBERG GROUP
|
TABLET; CONTROLLED-RELEASE; ORAL |
Approved |
7/15/2005 |
CHLORHEXIDINE GLUCONATE 2% W/V
ISOPROPYL ALCOHOL 70% V/V
|
05P-0226/CP1
APLICARE
|
PREOPERATIVE SKIN PREP |
Pending |
6/17/2005 |
RANITIDINE HYDROCHLORIDE 15 MG BASE/ML
|
05P-0228/CP1
LACHMAN CONSULTANT SERVICES
|
SUSPENSION |
Withdrawn |
5/24/2006 |
LIDOCAINE HYDROCHLORIDE 2%
|
05P-0243/CP1
INT. INST. FOR CLIN. RESEARCH
|
TOPICAL (SPRAY) |
Pending |
1/17/2006 |
VANCOMYCIN HYDROCHLORIDE 100 GRAM VIAL
|
05P-0242/CP1
SAMSON MEDICAL TECHNOLOGIES
|
FOR INJECTION |
Approved |
4/19/2006 |
METHYLPHENIDATE HYDROCHLORIDE 72 MG
|
05P-0257/CP1
THE WEINBERG GROUP
|
TABLET; EXTENDED-RELEASE; ORAL |
Approved |
11/14/2005 |
WARFARIN SODIUM 1 MG/ML
|
05P-0307/CP1
MORTON GROVE PHARMACEUTICALS
|
ORAL SOLUTION |
Pending |
8/9/2005 |
URSODIOL 20 MG/ML
|
05P-0315/CP1
CANREG
|
ORAL SUSPENSION |
Pending |
8/19/2005 |
LOSARTAN POTASSIUM 10 MG/ML
|
05P-0351/CP1
MORTON GROVE
|
ORAL SOLUTION |
Denied |
9/25/2007 |
CARBOPLATIN 1000 MG/100 ML
MULTIPLE DOSE VIAL
|
05P-0398/CP1
LACHMAN CONSULTANT SERVICES
|
INJECTION |
Pending |
10/5/2005 |
BENZPHETAMINE HYDROCHLORIDE 25 MG, 50 MG
|
05P-0406/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULES |
Approved |
6/27/2007 |
EFAVIRENZ 50 MG/100 MG/200 MG
|
05P-0407/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS FOR ORAL SUSPENSION |
Pending |
10/12/2005 |
DEXTROAMPHETAMINE SULFATE 2.5 MG, 7.5 MG,
15 MG, 20 MG, 30 MG
|
05P-0418/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Withdrawn |
11/1/2005 |
TRETINOIN 0.0375%, 0.075%
|
05P-0417/CP1
TRIAX PHARMACEUTICALS
|
CREAM |
Approved |
5/9/2007 |
RAMIPRIL 1.25 MG, 2.5 MG
5 MG AND 10 MG
|
05P-0460/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Pending |
1/30/2006 |
RAMIPRIL 1.25MG, 2.5MG, 5MG,
10MG
|
05P-0472/CP1
PHARMACEUTICAL PATENT ATTORNEY
|
TABLETS |
Pending |
11/28/2005 |
MELOXICAM 7.5MG, 15MG
|
05P-0480/CP1
CAMARGO PHARMACEUTICAL SERVICE
|
ORALLY DISINTEGRATING TABLETS |
Pending |
12/5/2005 |
IRINOTECAN HYDROCHLORIDE 500 MG/25 ML
|
05P-0496/CP1
MAYNE PHARMA
|
INJECTION |
Approved |
1/16/2007 |
OXYCODONE HYDROCHLORIDE 10 MG/5 ML
ACETAMINOPHEN 300 MG/5 ML
|
06P-0007/CP1
LACHMAN CONSULTANT SERVICES
|
ORAL SOLUTION |
Approved |
1/16/2007 |
METHOCARBAMOL 1000 MG
|
06P-0002/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Pending |
1/17/2006 |
PREDNISOLONE SODIUM PHOSPHATE 10 MG/5 ML
|
06P-0072/CP1
OLSSON, FRANK AND WEEDA
|
ORAL SOLUTION |
Withdrawn |
4/11/2006 |
RAMIPRIL 1.25, 2.50, 5, 10 MG
|
06P-0084/CP1
KING & SPALDING
|
TABLETS |
Pending |
3/1/2006 |
BUTALBITAL 50 MG
ACETAMINOPHEN 300 MG
|
06P-0086/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Approved |
8/18/2006 |
PROPOXYPHENE NAPSYLATE 50 MG, 100 MG
ACETAMINOPHEN 300 MG
|
06P-0087/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Approved |
12/18/2008 |
PIPERACILLIN 12 GRAMS
TAZOBACTAM 1.5 GRAMS
|
06P-0095/CP1
SANDOZ
|
INJECTION |
Pending |
3/10/2006 |
LOPERAMIDE HYDROCHLORIDE 2 MG
|
06P-0098/CP1
MONOSOL RX
|
ORALLY DISSOLVING STRIP |
Withdrawn |
5/10/2006 |
TEMAZEPAM 7.5 MG, 15 MG
22.5 MG AND 30 MG
|
06P-0103/CP1
LACHMAN CONSULTANT SERVICES
|
ORALLY DISINTEGRATING TABLETS |
Pending |
3/21/2006 |
OMEPRAZOLE 20 MG
|
06P-0117/CP1
QPHARMA, LLC
|
DELAYED-RELEASE TABLET; ORAL |
Pending |
3/15/2006 |
CETIRIZINE HYDROCHLORIDE 5 MG, 10 MG
|
06P-0122/CP1
LACHMAN CONSULTANT SERVICES
|
ORALLY DISINTEGRATING TABLETS |
Pending |
3/24/2006 |
EPIRUBICIN HYDROCHLORIDE 2 MG/ML
10 MG/5 ML
|
06P-0131/CP1
AAC CONSULTING
|
INJECTION |
Pending |
4/11/2006 |
GEMCITABINE 2 GM/VIAL
|
06P-0145/CP1
LACHMAN CONSULTANT SERVICES
|
INJECTION |
Approved |
8/22/2007 |
OXYCODONE 7.5 MG, 10 MG
ACETAMINOPHEN 325 MG
|
06P-0167/CP2
ARNALL GOLDEN GREGORY
|
ORALLY DISINTEGRATING TABLET |
Pending |
4/26/2006 |
OXYCODONE 2.5 MG, 5 MG
ACETAMINOPHEN 325 MG
|
06P-0167/CP1
ARNALL GOLDEN GREGORY
|
ORALLY DISINTEGRATING TABLET |
Pending |
4/26/2006 |
METHOTREXATE 100 MG/ML
|
06P-0177/CP1
SICOR PHARMACEUTICALS
|
INJECTION |
Withdrawn |
3/23/2007 |
LORATADINE 10 MG
|
06P-0208/CP1
STRIDES
|
CAPSULES, SOFT GELATIN |
Pending |
6/12/2006 |
CETIRIZINE HYDROCHLORIDE 5 MG; 10 MG
|
06P-0207/CP1
STRIDES
|
CAPSULES, SOFT GELATIN |
Pending |
6/12/2006 |
LIDOCAINE HYDROCHLORIDE 12 MG
|
06P-0230/CP1
ODAN LABORATORIES
|
ORAL NON-AEROSOL SPRAY |
Pending |
6/15/2006 |
LOPERAMIDE HYDROCHLORIDE 2 MG
|
06P-0253/CP1
AAC CONSULTING
|
ORALLY DISSOLVING STRIP |
Pending |
7/5/2006 |
CEFDINIR 187.5, 250, 300 MG
|
06P-0265/CP1
LUPIN PHARMACEUTICALS
|
CHEWABLE TABLETS |
Pending |
7/5/2006 |
DEXTROAMPHETAMINE SULFATE 2.5 MG, 7.5 MG
15 MG, 20 MG, 30 MG
|
06P-0267/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Approved |
3/20/2007 |
WATER FOR INJECTION 3 ML, 5 ML, 15 ML
30 ML
|
06P-0273/CP1
BECKLOFF ASSOCIATES
|
INJECTION |
Approved |
8/22/2007 |
SODIUM CHLORIDE 3 ML, 5 ML,
15 ML, 30 ML
|
06P-0272/CP1
BECKLOFF ASSOCIATES
|
INJECTION |
Approved |
8/22/2007 |
ALPRAZOLAM 0.25 MG
|
06P-0288/CP1
BECKLOFF ASSOCIATES
|
ORALLY DISINTEGRATING TABLETS |
Pending |
8/1/2006 |
GLYCOPYRROLATE 1.5 MG
|
06P-0300/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Approved |
3/20/2007 |
SODIUM CHLORIDE 0.9%, 1 ML SYRINGE
|
06P-0302/CP1
BECKLOFF ASSOCIATES
|
INJECTION |
Approved |
8/22/2007 |
LOPERAMIDE HYDROCHLORIDE 2 MG
|
06P-0305/CP1
MONOSOL RX
|
ORALLY DISSOLVING STRIPS |
Pending |
8/10/2006 |
ALCLOMETASONE DIPROPIONATE 0.05%
|
06P-0369/CP1
KIRKPATRICK & LOCKHART
|
LOTION; TOPICAL |
Pending |
9/13/2006 |
CLOBETASOL PROPIONATE 0.05%
|
06P-0387/CP1
PADDOCK LABORATORIES
|
FOAM |
Pending |
9/21/2006 |
METOPROLOL TARTRATE 12.5 MG
|
06P-0395/CP1
KENDLE INTERNATIONAL
|
TABLETS |
Withdrawn |
8/27/2008 |
FEXOFENADINE HYDROCHLORIDE 30 MG/5 ML
60 MG/5 ML
|
06P-0397/CP1
LUPIN PHARMACEUTICALS
|
ORAL SUSPENSION |
Pending |
10/6/2006 |
DOXYCYCLINE (MONOHYDRATE) 125 MG
|
06P-0417/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Pending |
10/24/2006 |
BETAMETHASONE VALERATE 0.12%
|
06P-0438/CP1
OLSSON, FRANK AND WEEDA
|
NON-AEROSOL FOAM |
Pending |
11/7/2006 |
IBUPROFEN POTASSIUM 200 MG
PHENYLEPHRINE HYDROCHLORIDE 10 MG
|
06P-0469/CP1
STRIDES
|
CAPSULES |
Pending |
11/28/2006 |
POTASSIUM CHLORIDE 10%, 5%
|
06P-0477/CP1
KING & SPALDING
|
ORAL SOLUTION |
Pending |
12/11/2006 |
OXYCODONE HYDROCHLORIDE 5 MG
|
06P-0481/CP1
ACTAVIS TOTOWA
|
CAPSULES |
Pending |
12/11/2006 |
PROPOXYPHENE NAPSYLATE 100 MG
ACETAMINOPHEN 400 MG
|
06P-0503/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Approved |
3/5/2009 |
URSODIOL 100, 200, 400 MG
|
06P-0505/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULES |
Approved |
8/28/2007 |
METHOTREXATE 1000 MG/ML
10 ML VIAL
|
06P-0507/CP1
SICOR PHARMACEUTICALS
|
INJECTION |
Pending |
1/11/2007 |
PROPOXYPHENE HYDROCHLORIDE 65 MG
ACETAMINOPHEN 325 MG
|
06P-0510/CP1
LACHMAN CONSULTANTS
|
TABLETS |
Approved |
3/5/2009 |
VANCOMYCIN HYDROCHLORIDE 750 MG
|
06P-0534/CP1
KING ANS SPALDING
|
INJECTION |
Approved |
8/22/2007 |
VANCOMYCIN HYDROCHLORIDE 750 MG
|
06P-0533/CP1
KING & SPALDING
|
INJECTION |
Approved |
8/22/2007 |
FENTANYL CITRATE 1000 MCG, 1400 MCG
|
07P-0022/CP1
LACHMAN CONSULTANT SERVICES
|
ORAL TRANSMUCOSAL |
Pending |
1/19/2007 |
ACETAMINOPHEN 400 MG
BUTALBITAL 50 MG
|
07P-0030/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULES |
Approved |
6/9/2008 |
LORATADINE 5 MG, 10 MG
|
07P-0037/CP1
LACHMAN CONSULTANT SERVICES
|
ORALLY-DISSOLVING STRIPS |
Pending |
2/6/2007 |
ZOLPIDEM TARTRATE 5 MG, 10 MG
|
07P-0042/CP1
LACHMAN CONSULTANT SERVICES
|
ORALLY DISSOLVING STRIPS |
Pending |
2/12/2007 |
ONDANSETRON 4 MG, 8 MG
16 MG, 24 MG
|
07P-0043/CP1
LACHMAN CONSULTANT SERVICES
|
ORALLY DISSOLVING STRIPS |
Pending |
2/12/2007 |
CIPROFLOXACIN HYDROCHLORIDE 100 MG, 250 MG
500 MG, 750 MG
|
07P-0100/CP1
JRRAPOZA ASSOCIATES
|
CAPSULES |
Pending |
4/4/2007 |
PROMETHAZINE HYDROCHLORIDE 6.25 MG
HYDROCODONE BITARTRATE 2.5 MG, 1.67 MG
|
07P-0076/CP1
SOVEREIGN PHARMACEUTICALS
|
SYRUP |
Pending |
3/15/2007 |
METOPROLOL TARTRATE 37.5 MG, 75 MG
|
07P-0072/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Pending |
3/15/2007 |
BISOPROLOL FUMARATE 5 MG, 10 MG, 20 MG
HYDROCHLOROTHIAZIDE 12.5 MG
|
07P-0071/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Pending |
3/15/2007 |
CARVEDILOL PHOSPHATE 10, 20, 40, 80 MG
|
07P-0103/CP1
KELLER AND HECKMAN
|
TABLET; EXTENDED-RELEASE; ORAL |
Pending |
4/2/2007 |
AMINO ACID 15%
|
07P-0113/CP1
B BRAUN MEDICAL
|
INJECTION |
Pending |
4/4/2007 |
HYDROCODONE BITARTRATE 2.5 MG PER 5 ML
HOMATROPINE METHYLBROMIDE 0.75 MG PER 5 ML
|
07P-0119/CP1
LACHMAN CONSULTANT SERVICES
|
SYRUP |
Pending |
4/5/2007 |
HYDROCODONE BITARTRATE 2.5 MG
HOMATROPINE METHYLBROMIDE 0.75 MG
|
07P-0134/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Pending |
4/12/2007 |
CLINDAMYCIN PHOSPHATE 1%
|
07P-0124/CP1
OLSSON, FRANK AND WEEDA
|
FOAM; NON-AEROSOL |
Pending |
4/4/2007 |
FLUDEOXYGLUCOSE F18 0.9-475 MCI/ML
|
07P-0126/CP1
PFI LLC
|
INJECTION |
Pending |
4/9/2007 |
DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML
1 ML FILL SIZE
|
07P-0167/CP1
AKORN STRIDES
|
INJECTION |
Pending |
5/9/2007 |
ACETAMINOPHEN 650 MG
BUTALBITAL 50 MG
|
07P-0194/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULES |
Pending |
5/22/2007 |
MEMANTINE HYDROCHLORIDE 5 MG, 10 MG
|
07P-0203/CP1
ORGENUS PHARMA
|
ORALLY DISINTEGRATING TABLETS |
Pending |
5/23/2007 |
CEFAZOLIN 2 G VIALS
|
07P-0214/CP1
SANDOZ
|
INJECTION |
Pending |
6/5/2007 |
DEFEROXAMINE MESYLATE 1 GRAM
|
07P-0216/CP1
BEN VENUE LABORATORIES
|
INJECTION |
Pending |
6/7/2007 |
DONEPEZIL HYDROCHLORIDE 5 MG, 10 MG
|
07P-0226/CP1
LACHMAN CONSULTANT SERVICES
|
ORALLY DISSOLVING FILM STRIPS |
Pending |
6/18/2007 |
ESCITALOPRAM OXALATE 5 MG, 10 MG, 20 MG
|
07P-0239/CP1
LACHMAN CONSULTANT SERVICES
|
ORALLY DISSOLVING FILM STRIPS |
Pending |
6/21/2007 |
DIFLUNISAL USP 375 MG
|
07P-0247/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Pending |
6/26/2007 |
ACETAMINOPHEN 534.6 MG
CAFFEINE 45 MG
|
07P-0272/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Pending |
7/16/2007 |
NABUMETONE 1000 MG
|
07P-0275/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Pending |
7/16/2007 |
FENOPROFEN CALCIUM 400 MG
|
07P-0293/CP1
EMCURE PHARMACEUTICALS
|
CAPSULES |
Pending |
7/26/2007 |
AMINO ACID 15 % 1 L GLASS BOTTLE
|
07P-0300/CP1
B. BRAUN MEDICAL
|
INJECTION |
Pending |
8/8/2007 |
HYDROCODONE BITARTRATE 5 MG
HOMATROPINE METHYLBROMIDE 1.5 MG
|
07P-0307/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULES |
Pending |
8/10/2007 |
RITONAVIR 100 MG
|
07P-0336/CP1
MATRIX LABORATORIES
|
TABLETS |
Pending |
9/10/2007 |
ZALEPLON 7.5 MG
|
07P-0398/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULES |
Pending |
10/23/2007 |
LEVOMETHADYL ACETATE HCL 10 MG, 20 MG, 40 MG
|
07P-0403/CP1
VCU SCHOOL OF MEDICINE
|
TABLETS |
Pending |
10/23/2007 |
CEFIXIME 100 MG/ML
|
07P-0404/CP1
LUPIN PHARMACEUTICALS
|
ORAL SUSPENSION |
Pending |
10/31/2007 |
ABACAVIR SULFATE 60 MG
|
07P-0407/CP1
MATRIX LABORATORIES
|
TABLETS |
Pending |
10/31/2007 |
DICLOFENAC SODIUM 50 MG, 75 MG
MISOPROSTOL 200 MCG
|
07P-0428/CP1
KING & SPALDING LLP
|
CAPSULES |
Pending |
11/5/2007 |
LOPINAVIR 100 MG
RITONAVIR 25 MG
|
07P-0437/CP1
MATRIX LABORATORIES
|
TABLETS |
Pending |
11/13/2007 |
OXALIPLATIN 200 MG/VIAL
|
07P-0450/CP1
EBEWE PARENTA PHARMACEUTICALS
|
INJECTION |
Pending |
11/19/2007 |
LIDOCAINE 10 MG
|
08P-0001/CP1
ODAN LABORATORIES
|
ORAL SPRAY NON-AEROSOL |
Pending |
1/7/2007 |
FLUOROURACIL 1 GM/20 ML
|
08P-0003/CP1
EBEWE PARENTA
|
INJECTION |
Pending |
1/10/2007 |
ESOMEPRAZOLE MAGNESIUM 20 MG, 40 MG
|
08P-0080/CP1
LUPIN PHARMACEUTICALS
|
TABLETS, DELAYED-RELEASE |
Pending |
2/7/2008 |
ATORVASTATIN CALCIUM 10 MG, 20 MG
40 MG, 80 MG
|
08P-0085/CP1
LUPIN PHARMACEUTICALS
|
CAPSULES |
Pending |
2/7/2008 |
ACETAMINOPHEN 500 MG
CODEINE PHOSPHATE 15 MG, 30 MG, 60 MG
|
08P-0127/CP1
LACHMAN CONSULTANT SERVICES
|
TABLET, EFFERVESCENT |
Pending |
2/26/2008 |
HYDROCODONE BITARTRATE 2.5, 5, 7.5, 10 MG
ACETAMINOPHEN 500 MG
|
08P-0134/CP1
LACHMAN CONSULTANT SERVICES
|
TABLET; EFFERVESCENT |
Pending |
3/10/2008 |
BUTALBITAL 50 MG
ASPIRIN 500 MG
|
08P-0156/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULES |
Pending |
3/18/2008 |
BUTALBITAL 50 MG
ASPIRIN 500 MG
|
08P-0155/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULES |
Pending |
3/12/2008 |
CARBINOXAMINE MALEATE 6 MG
|
08P-0167/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Pending |
3/17/2008 |
CALCIUM ACETATE 667 MG/5 ML
|
08P-0175/CP1
BECKLOFF ASSOCIATES
|
ORAL SOLUTION |
Withdrawn |
3/19/2008 |
ALLOPURINOL 100 MG PER 5 ML
|
08P-0209/CP1
NEW ENGLAND BIOMEDICAL RESEARC
|
SUSPENSION |
Pending |
4/16/2008 |
ESCITALOPRAM OXALATE 5 MG, 10 MG, 20 MG
|
08P-0216/CP1
LUPIN PHARMACEUTICALS
|
TABLETS, ORALLY DISINTEGRATING |
Pending |
4/16/2008 |
VENLAFAXINE HYDROCHLORIDE 225 MG, 300 MG
|
08P-0247/CP1
KENDLE REGULATORY AFFAIRS
|
TABLET; EXTENDED-RELEASE; ORAL |
Withdrawn |
11/21/2008 |
ISONIAZID 100 MG, 300 MG
|
08P-0251/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS; ORAL SUSPENSION |
Pending |
5/5/2008 |
CLOZAPINE 150 MG
|
08P-0289/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Pending |
5/19/2008 |
CLOZAPINE 150 MG, 200 MG
|
08P-0294/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS; ORAL DISINTEGRATING |
Pending |
5/19/2008 |
GRISEOFULVIN ULTRAMICROSIZE 250 MG/5 ML
|
08P-0303/CP1
EMCURE PHARMACEUTICALS
|
SUSPENSION; ORAL |
Pending |
6/3/2008 |
TRAMADOL HYDROCHLORIDE 100 MG
|
08P-0327/CP1
KENDLE REGULATORY AFFAIRS
|
TABLETS |
Pending |
6/6/2008 |
BACLOFEN 5 MG
|
08P-0325/CP1
KENDLE REGULATORY AFFAIRS
|
TABLETS |
Pending |
6/6/2008 |
NIACIN 375 MG, 500 MG
|
08P-0340/CP1
LUPIN PHARMACEUTICALS
|
CAPSULE, EXTENDED RELEASE |
Pending |
6/18/2008 |
ALBUTEROL SULFATE 0.25%
|
08P-0344/CP1
NEPHRON PHARMACEUTICALS
|
SOLUTION; INHALATION |
Pending |
6/18/2008 |
TOPOTECAN 1 MG/ML
|
08P-0348/CP1
OLSSON FRANK WEEDA
|
SOLUTION; INJECTABLE |
Pending |
6/18/2008 |
GEMCITABINE HCL 38 MG/ML
|
08P-0392/CP1
OLSSON FRANK & WEEDA
|
INJECTION |
Pending |
7/17/2008 |
MORPHINE SULFATE 5 MG, 10 MG, 20 MG
|
08P-0401/CP1
RAKOCZY MOLINO MAZZOCHI SIWIK
|
TABLETS |
Pending |
7/17/2008 |
ZIDOVUDINE 100 MG
|
08P-0407/CP1
MATRIX LABORATORIES
|
TABLETS |
Pending |
7/31/2008 |
RIFAXIMIN 200 MG
|
08P-0404/CP1
STRIDES ARCOLAB
|
CAPSULES |
Pending |
7/18/2008 |
GLYCOPYRROLATE 1 MG/5 ML
|
08P-0414/CP1
LACHMAN CONSULTANT SERVICES
|
SOLUTION |
Pending |
7/22/2008 |
AZACITIDINE 150 MG/VIAL
|
08P-0418/CP1
REGULUS PHARMACEUTICAL
|
INJECTION |
Pending |
7/28/2008 |
PHYTONADIONE 2.5 MG,7.5 MG, 10 MG
|
08P-O421/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Pending |
7/28/2008 |
OLSALAZINE SODIUM 500 MG
|
08P-0422/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULES |
Pending |
7/28/2008 |
HYDROCODONE BITARTRATE 2.5, 5, 7.5, 10 MG
ASPIRIN 325 MG
|
08P-0438/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Pending |
8/12/2008 |
EFAVIRENZ 50 MG, 100 MG,200 MG
|
08P-0460/CP1
MATRIX LABORATORIES
|
TABLETS |
Pending |
8/27/2008 |
PENICILLAMINE 500 MG
|
08P-0463/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULES |
Pending |
8/20/2008 |
CLONIDINE HYDROCHLORIDE 0.05 MG
|
08P-0489/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Pending |
10/10/2008 |
CEFEPIME 100 GRAM
|
08P-0539/CP1
SAMSOM MEDICAL TECHNOLOGIES
|
INJECTION USP |
Pending |
10/8/2008 |
CEFIXIME 200 MG, 400 MG
|
08P-0534/CP1
LUPIN PHARMACEUTICALS
|
CAPSULES |
Pending |
10/8/2008 |
TOPOTECAN HYDROCHLORIDE 1 MG/1 ML; 3 MG/3 ML
4 MG/4 ML
|
08P-0591/CP1
REGULUS PHARMACEUTICAL
|
SOLUTION |
Pending |
11/18/2008 |
PREDNISOLONE SODIUM PHOSPHATE 30 MG/5ML
|
08P-0584/CP1
COHEN TAUBER SPIEVACK & WAGNER
|
SOLUTION |
Pending |
12/1/2008 |
OXYCODONE HYDROCHLORIDE 5 MG
|
08P-0598/CP1
VINTAGE PHARMACEUTICALS
|
CAPSULES |
Pending |
12/1/2008 |
SULINDAC 200 MG
|
08P-0647/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULES |
Pending |
12/18/2009 |
MINOXIDIL 2%, 5% W/W
|
08P-0643/CP1
BAKER & HOSTETLER
|
CREAM; TOPICAL |
Pending |
12/18/2008 |
CARBOPLATIN 1000 MG/100 ML
|
08P-0660/CP1
ONCOTHERAPIES
|
INJECTION |
Pending |
1/5/2009 |
RIFAMPIN 50 MG/5 ML
100 MG/5 ML
|
08P-0662/CP1
LACHMAN CONSULTANT SERVICES
|
SUSPENSION; ORAL |
Pending |
1/5/2009 |
CLOZAPINE 50 MG/ML
|
09P-0046/CP1
LACHMAN CONSULTANT SERVICES
|
ORAL SUSPENSION |
Pending |
2/6/2009 |
SODIUM ACETATE 32.8%
|
09P-0055/CP1
APP PHARMACEUTICALS
|
INJECTION |
Pending |
2/17/2009 |
BACTERIOSTATIC WATER 20 ML/30 CC VIAL
|
09P-0067/CP1
APP PHARMACEUTICALS
|
INJECTION |
Pending |
2/18/2009 |
POTASSIUM ACETATE 100 ML/100 CC VIAL
|
09P-0068/CP1
APP PHARMACEUTICALS
|
INJECTION |
Pending |
2/18/2009 |
SODIUM ACETATE 16.4%
|
09P-0055/CP2
APP PHARMACEUTICALS
|
INJECTION |
Pending |
2/17/2009 |
GEMCITABINE HYDROCHLORIDE 38 MG/ML
|
09P-0076/CP1
PHARMAFORCE
|
INJECTION |
Pending |
2/19/2009 |
SODIUM CHLORIDE 100 ML/100 CC
200 ML/200 CC
|
09P-0069/CP1
APP PHARMACEUTICALS
|
INJECTION |
Pending |
2/19/2009 |
STERILE WATER 5 ML/6 CC VIAL
100 ML/100 CC VIAL
|
09P-0070/CP1
APP PHARMACEUTICALS
|
INJECTION |
Pending |
2/17/2009 |
TOPOTECAN HYDROCHLORIDE 1 MG/ML
|
09P-0077/CP1
PHARMAFORCE
|
INJECTION |
Pending |
2/19/2009 |
SODIUM PHOSPHATES 5 ML/10 CC
50 ML/50 CC
|
09P-0080/CP1
APP PHARMACEUTICALS
|
INJECTION |
Pending |
2/19/2009 |
POTASSIUM PHOSPHATES 5 ML/10 CC
15 ML/30 CC
|
09P-0082/CP1
APP PHARMACEUTICALS
|
INJECTION |
Withdrawn |
2/19/2009 |
MAGNESIUM SULFATE 20 ML AND 50 ML
|
09P-0091/CP1
APP PHARMACEUTICALS
|
INJECTION |
Withdrawn |
2/26/2009 |
SODIUM BICARBONATE 5 ML
|
09P-0085/CP1
APP PHARMACEUTICALS
|
INJECTION |
Pending |
2/26/2009 |
POTASSIUM ACETATE 50 ML
|
09P-0102/CP1
APP PHARMACEUTICALS
|
INJECTION |
Pending |
2/26/2009 |
SODIUM CHLORIDE 100 ML
|
09P-0104/CP1
APP PHARMACEUTICALS
|
INJECTION |
Pending |
2/26/2009 |
SODIUM ACETATE 50 ML
|
09P-0109/CP1
APP PHARMACEUTICALS
|
INJECTION |
Pending |
3/3/2009 |
SODIUM ACETATE 50 ML
|
09P-0107/CP1
APP PHARMACEUTICALS
|
INJECTION |
Pending |
3/3/2009 |
POTASSIUM ACETATE 50 ML
|
09P-0108/CP1
APP PHARMACEUTICALS
|
INJECTION |
Pending |
3/3/2009 |
METRONIDAZOLE 50 MG
|
09P-0121/CP1
PHARMENG TECHNOLOGY INC.
|
TABLETS |
Pending |
3/4/2009 |
