OGD Suitability Tracking Reports (Sorted by Drug Name)

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FDA/Center for Drug Evaluation and Research

OGD Suitability Tracking Report
(Sorted by Drug Name)
as of August 18, 2008

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ACETAMINOPHEN 120 MG CODEINE PHOSPHATE 12 MG	94P-0182/CP1 WE PHARMS	CHEWABLE TABLET	Withdrawn	3/26/2007
ACETAMINOPHEN 150 MG ASPIRIN 180 MG	94P-0212/CP1 MIKART	TABLET	Withdrawn	3/26/2007
ACETAMINOPHEN 150 MG ASPIRIN 180 MG	92P-0282/CP4 MIKART	CAPSULE OR TABLET	Withdrawn	3/26/2007
ACETAMINOPHEN 150 MG ASPIRIN 180 MG	92P-0282/CP3 MIKART	CAPSULE OR TABLET	Withdrawn	3/26/2007
ACETAMINOPHEN 150 MG ASPIRIN 180 MG	92P-0282/CP2 MIKART	CAPSULE OR TABLET	Withdrawn	3/26/2007
ACETAMINOPHEN 150 MG ASPIRIN 180 MG	94P-0211/CP1 MIKART	TABLET	Withdrawn	3/26/2007
ACETAMINOPHEN 150 MG ASPIRIN 180 MG	94P-0210/CP1 MIKART	TABLET	Withdrawn	3/26/2007
ACETAMINOPHEN 150 MG ASPIRIN 180 MG	92P-0282/CP1 MIKART	CAPSULE OR TABLET	Withdrawn	3/26/2007
ACETAMINOPHEN 160 MG/5ML CODEINE PHOSPHATE 6 MG/5 ML	87P-0323/CP KLEINFELD, KAPLAN & BECKER	SYRUP	Withdrawn	3/26/2007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ACETAMINOPHEN 300 MG CODEINE PHOSPHATE 30 MG	85P-0543/CP SOFTAN	SOFT GELATIN CAPSULE	Withdrawn	3/26/2007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ACETAMINOPHEN 325 MG BUTALBITAL 50 MG	93P-0346/CP1 MIKART	CAPSULE OR TABLET	Withdrawn	3/26/2007
ACETAMINOPHEN 325 MG ASPIRIN 325 MG	86P-0361/CP BOCK PHARMA	TABLET	Withdrawn	3/26/2007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ACETAMINOPHEN 500 MG CODEINE PHOSPHATE 30 MG OR 60 MG	84P-0228/CP1 MCNEIL	CAPSULE	Withdrawn	3/26/2007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

Date created: January 5, 2004; Last updated: August 20, 2008