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| Dockets Entered
On March 1, 2007
Table of Contents
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| Docket
#
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| Title
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| 1982N-0032
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| Drug Products List for ANDA's
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| 1984N-0116
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| DISOPYRAMIDE PHOSPHATE
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| 1984P-0228
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| EXTEND LIST OF DRUG PROD SUITABLE FOR ANDA APPLICATIONS
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| |
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| 1985P-0067
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| ANDA SUITABILITY METHYLTESTOSTERONE 25MG
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| 1985P-0074
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| ANDA SUITABILITY FOR HYDRALAZINE HYDROCHLORIDE ORAL SOLUT
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| 1985P-0081
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| ANDA SUITABILITY FOR FLURAZEPAN HYDROCHLORIDE INTENSOL TM
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| 1985P-0084
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| ANDA SUITABILITY RE VINCRISTINE SULFATE FOR INJECTION
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| 1985P-0091
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| ANDA SUITABILITY FOR FLURAZEPAM HYDROCHLORIDE ORAL SOLUTI
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| 1985P-0129
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| ANDA SUITABILITY RE: PROPRANOLOL HC1 TABLETS (PROBLOK)
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| 1985P-0140
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| ANDA PSEUDOEPHEDRINE/DEXBROMPHENIRAMINE MALAETE COMBINATI
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| 1985P-0147
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| ANDA SUITABILITY FOR KETOCONAZOLE TABLETS 200MG
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| 1985P-0197
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| ANDA SUITABILITY RE PROPRANOLOL HYDROCHLORIDE 80 120 160
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| 1985P-0215
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| ANDA SUITABILITY RE DISULFIRAM ORAL SUSPENSION
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| 1985P-0238
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| ANDA SUIT COMBO/PHENYLPROPANOLAMINE/DEXBROMPHENIRAMINE
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| 1985P-0269
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| ANDA SUIT/DEXBROMPHENIRAMINE/PPA/CODEINE PHOSPHATE COMBO
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| 1985P-0423
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| ANDA SUITABILITY RE: BENZTROPINE MESYLTATE SYRUP
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| 1985P-0492
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| ANDA SUIT RE; 75MG PPA HCL & 1 MG AZATADINE MALEATE CAPSU
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| 1985P-0499
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| ANDA SUITABILITY RE: DIAZEPAM SYRUP 2MG/5ML
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| 1985P-0510
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| ANDA SUITABILITY RE SPIRONOLACTONE SYRUP
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| 1985P-0515
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| ANDA SUIT RE: ATIVAN (LORAZEPAM) TABLETS 0.5MG,1MG,& 2MG
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| 1985P-0516
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| ANDA SUIT RE: SERAX (OXAZEPAM) TABLET 15MG & 30MG
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| 1985P-0543
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| ANDA SOFT GELATIN CAPSULE COMBINATION MARKETED AS TABLET
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| 1985P-0563
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| SOFT GELATIN CAPSULES CONSISTING OF IBUPROFEN RE: ANDA
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| 1985P-0581
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| ACETAMINOPHEN 500MG & PROPOXYPHENE 32MG SOFT GEL CAP/ANDA
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| 1986P-0045
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| PROPRANOLOL HCL 10, 20, 40, 60, 80 & 90MG CAPSULES ANDA
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| 1986P-0055
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| SPIRONOLACTONE SUSPENSION 25MG/5ML RE: ANDA SUITABILITY
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| 1986P-0123
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| SEEKING THE SUITABILITY OF ANDA FOR ORAL CHOLESTYRAMINE
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| 1986P-0200
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| ACETAMINOPHEN 650MG & CODEINE PHOSPHATE 15MG ANDA SUIT
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| 1986P-0242
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| FLOXURIDINE INJECTION 100 MG/ML 5ML VIAL ANDA SUITABILITY
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| 1986P-0292
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| LORAZEPAM ORAL SOLUTION 1 MG PER 5 ML ANDA SUIT
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| 1986P-0359
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| ASPIRIN, CAFFEINE & DIHYDROCODEINE BITARTRATE TAB ANDA SU
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| 1986P-0361
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| ACETAMINOPHEN, ASPIRIN & CODEINE PHOSPHATE ANDA SUITABILI
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| 1986P-0427
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| HYDROCHLOROTHIAZIDE 50MG & TRIAMTERENE 75MG CAP ANDA SUIT
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| 1986P-0474
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| ANDA CHOLESTYRAMINE CAPSULE 4 G
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| 1987P-0004
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| CORTICOSTEROID, REQUEST FOR ANDA SUITABILITY .05% FLUOCIN
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| 1987P-0037
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| LORAZEPAM SOFT GELATIN CAPSULES IN 0.5MG,1.0MG & 2.0MG
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| 1987P-0101
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| ANDA Suit Re Verapamil HCI Oral Solution 120 MG/5ML
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| 1987P-0233
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| VERAPAMIL HYDROCHLORIDE CAPSULES 60MG 120MG 180MG ANDA
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| 1987P-0242
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| IBUPROFEN 800MG SOFT GELATIN CAPSULES ANDA SUITABILITY
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| 1987P-0265
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| PHENYLPROPANOLAMINE HCL W/DEXBROMPHENIRAMINE MALEATE TAB
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| 1987P-0268
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| LOPERAMIDE HYDROCHLORIDE 2 MG CAPLET ANDA SUITABLITY
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| 1987P-0301
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| ANDA SUITABILITY FOR CHOLESTYRAMINE RESIN
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| 1987P-0314
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| ANDA: 1.34 MG CLEMASTINE FUMARATE & 120 MG PSEUDOEPHEDRIN
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| 1987P-0323
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| ANDA FOR TYLENOL WITH CODEINE ELIXIR
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| |
|
|
| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| |
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| 2002E-0150
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| Gynecare Intergel, U.S. Patent Extension No. 5,532,221
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| 2004P-0290
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| Refrain from approving any ANDA for a topical mupirocin calcium product containing the amorphous form of the active ingredient
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| |
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| |
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| |
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| 2006E-0486
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| Patent Extension Application for Rotateq (Rotavirus Vaccine, Live, Oral, Pentavalent), U.S. Patent No. 5,626,851
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| 2006P-0360
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| Determine that the discontinued formulation of Carbocaine Injection, 3% supplied in 1.8 mL cartridge was not discontinued for safety and efficacy reasons
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| 2006P-0364
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| Reformulation of central nervous system (CNS) stimulant drugs
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| 2006P-0371
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| Immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market in the United States
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| 2007N-0016
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| Sentinel Network To Promote Medical Product Safety
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| 2007P-0062
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| Determine Whether a Previously Listed Drug Eloxatin (oxaliplatin for injection) Lyophilized Powder for Infusion, 50 and 100 mg Vials Has Been Voluntarily Withdrawn From Sale for Safety or Efficacy Rea
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| 2007P-0070
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| Make fluoride a prescription drug for use in tooth application, tooth paste, and in bottled water
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| 2007P-0071
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| to permit an ANDA suitability for Bisoprolol Fumarate and Hydrochlorothiazide Tablets
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| 2007P-0072
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| to permit an ANDA suitability for Metoprolol Tartrate Tablets
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| 2007P-0074
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| Take specific action with respect to 21 CFR 341, the Final Monograph for Cough, Cold Allergy, Bronchodilator, Antiasthmatic Drug Products for Over-the-Counter Human Use
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| 1982N-0032
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| Drug Products List for ANDA's
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|
|
| NWL
1
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| FDA
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| Vol #:
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| 1
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|
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| 1984N-0116
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| DISOPYRAMIDE PHOSPHATE
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|
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| NWL
1
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| FDA
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| Vol #:
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| 1
|
| |
|
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| 1984P-0228
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| EXTEND LIST OF DRUG PROD SUITABLE FOR ANDA APPLICATIONS
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| |
|
|
| NWL
1
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| FDA
|
| Vol #:
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| 1
|
| |
|
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| 1985P-0067
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| ANDA SUITABILITY METHYLTESTOSTERONE 25MG
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|
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| NWL
1
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| FDA
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| Vol #:
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| 1
|
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|
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| 1985P-0074
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| ANDA SUITABILITY FOR HYDRALAZINE HYDROCHLORIDE ORAL SOLUT
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1985P-0081
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| ANDA SUITABILITY FOR FLURAZEPAN HYDROCHLORIDE INTENSOL TM
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1985P-0084
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| ANDA SUITABILITY RE VINCRISTINE SULFATE FOR INJECTION
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1985P-0091
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| ANDA SUITABILITY FOR FLURAZEPAM HYDROCHLORIDE ORAL SOLUTI
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1985P-0129
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| ANDA SUITABILITY RE: PROPRANOLOL HC1 TABLETS (PROBLOK)
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| NWL
1
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| FDA
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| Vol #:
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| 1
|
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| 1985P-0140
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| ANDA PSEUDOEPHEDRINE/DEXBROMPHENIRAMINE MALAETE COMBINATI
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| |
|
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| NWL
1
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| FDA
|
| Vol #:
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| 1
|
| |
|
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| 1985P-0147
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| ANDA SUITABILITY FOR KETOCONAZOLE TABLETS 200MG
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| |
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| NWL
1
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| FDA
|
| Vol #:
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| 1
|
| |
|
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| 1985P-0197
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| ANDA SUITABILITY RE PROPRANOLOL HYDROCHLORIDE 80 120 160
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| |
|
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| NWL
1
|
| FDA
|
| Vol #:
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| 1
|
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|
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| 1985P-0215
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| ANDA SUITABILITY RE DISULFIRAM ORAL SUSPENSION
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| |
|
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| NWL
1
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| FDA
|
| Vol #:
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| 1
|
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| 1985P-0238
|
| ANDA SUIT COMBO/PHENYLPROPANOLAMINE/DEXBROMPHENIRAMINE
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| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 1985P-0269
|
| ANDA SUIT/DEXBROMPHENIRAMINE/PPA/CODEINE PHOSPHATE COMBO
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| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
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| 1985P-0423
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| ANDA SUITABILITY RE: BENZTROPINE MESYLTATE SYRUP
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| |
|
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| NWL
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 1985P-0492
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| ANDA SUIT RE; 75MG PPA HCL & 1 MG AZATADINE MALEATE CAPSU
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| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
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| 1985P-0499
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| ANDA SUITABILITY RE: DIAZEPAM SYRUP 2MG/5ML
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| |
|
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| NWL
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
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| 1985P-0510
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| ANDA SUITABILITY RE SPIRONOLACTONE SYRUP
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| | | | | | | | |
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| |
|
| NWL
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 1985P-0515
|
| ANDA SUIT RE: ATIVAN (LORAZEPAM) TABLETS 0.5MG,1MG,& 2MG
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| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
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| 1
|
|
| |
|
| 1985P-0516
|
| ANDA SUIT RE: SERAX (OXAZEPAM) TABLET 15MG & 30MG
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
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| 1985P-0543
|
| ANDA SOFT GELATIN CAPSULE COMBINATION MARKETED AS TABLET
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1985P-0563
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| SOFT GELATIN CAPSULES CONSISTING OF IBUPROFEN RE: ANDA
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1985P-0581
|
| ACETAMINOPHEN 500MG & PROPOXYPHENE 32MG SOFT GEL CAP/ANDA
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
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| 1986P-0045
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| PROPRANOLOL HCL 10, 20, 40, 60, 80 & 90MG CAPSULES ANDA
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
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| 1986P-0055
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| SPIRONOLACTONE SUSPENSION 25MG/5ML RE: ANDA SUITABILITY
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 1986P-0123
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| SEEKING THE SUITABILITY OF ANDA FOR ORAL CHOLESTYRAMINE
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 1986P-0200
|
| ACETAMINOPHEN 650MG & CODEINE PHOSPHATE 15MG ANDA SUIT
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
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| 1986P-0242
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| FLOXURIDINE INJECTION 100 MG/ML 5ML VIAL ANDA SUITABILITY
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
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| 1986P-0292
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| LORAZEPAM ORAL SOLUTION 1 MG PER 5 ML ANDA SUIT
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
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| 1986P-0359
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| ASPIRIN, CAFFEINE & DIHYDROCODEINE BITARTRATE TAB ANDA SU
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1986P-0361
|
| ACETAMINOPHEN, ASPIRIN & CODEINE PHOSPHATE ANDA SUITABILI
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
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| 1986P-0427
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| HYDROCHLOROTHIAZIDE 50MG & TRIAMTERENE 75MG CAP ANDA SUIT
|
|
| | | | | | | | |
|
| |
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1986P-0474
|
| ANDA CHOLESTYRAMINE CAPSULE 4 G
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 1987P-0004
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| CORTICOSTEROID, REQUEST FOR ANDA SUITABILITY .05% FLUOCIN
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1987P-0037
|
| LORAZEPAM SOFT GELATIN CAPSULES IN 0.5MG,1.0MG & 2.0MG
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1987P-0101
|
| ANDA Suit Re Verapamil HCI Oral Solution 120 MG/5ML
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1987P-0233
|
| VERAPAMIL HYDROCHLORIDE CAPSULES 60MG 120MG 180MG ANDA
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1987P-0242
|
| IBUPROFEN 800MG SOFT GELATIN CAPSULES ANDA SUITABILITY
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1987P-0265
|
| PHENYLPROPANOLAMINE HCL W/DEXBROMPHENIRAMINE MALEATE TAB
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1987P-0268
|
| LOPERAMIDE HYDROCHLORIDE 2 MG CAPLET ANDA SUITABLITY
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 1987P-0301
|
| ANDA SUITABILITY FOR CHOLESTYRAMINE RESIN
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1987P-0314
|
| ANDA: 1.34 MG CLEMASTINE FUMARATE & 120 MG PSEUDOEPHEDRIN
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1987P-0323
|
| ANDA FOR TYLENOL WITH CODEINE ELIXIR
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| LET 19098
|
| NBTY Inc.
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19099
|
| NBTY Inc.
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19100
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19101
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19102
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 171
|
|
| | | | | | | |
|
| |
|
| LET 19103
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19104
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19105
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19106
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19107
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19108
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19109
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19110
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19111
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19112
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19113
|
| Fitness Labs Nutrition Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19114
|
| Fitness Labs Nutrition Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19115
|
| Fitness Labs Nutrition Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19116
|
| Fitness Labs Nutrition Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19117
|
| Fitness Labs Nutrition Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19118
|
| Arkopharma, LLC
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19119
|
| Arkopharma, LLC
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19120
|
| Arkopharma, LLC
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19121
|
| Arkopharma, LLC
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19122
|
| Arkopharma, LLC
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19123
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19124
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19125
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19126
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19127
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19128
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19129
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19130
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19131
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19132
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19133
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19134
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19135
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19136
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19137
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19138
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19139
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
|
| | | | | | | | |
|
| |
|
| LET 19140
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19141
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19142
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19143
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19144
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19145
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19146
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19147
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19148
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19149
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19150
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19151
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19152
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19153
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19154
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19155
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19156
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19157
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19158
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19159
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19160
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19161
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19162
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19163
|
| Univera LifeSciences, Inc.
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19164
|
| Univera LifeSciences, Inc.
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19165
|
| Univera LifeSciences, Inc.
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19166
|
| Univera LifeSciences, Inc.
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19167
|
| Bayer HealthCare LLC
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19168
|
| McLind Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
| |
|
|
| C 1410
|
| T. Morin
|
| Vol #:
|
| 262
|
| |
|
|
| 2002E-0150
|
| Gynecare Intergel, U.S. Patent Extension No. 5,532,221
|
| |
|
|
| LET 5
|
| U.S. Patent and Trademark Office to Dorsey & Whitney LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0290
|
| Refrain from approving any ANDA for a topical mupirocin calcium product containing the amorphous form of the active ingredient
|
| |
|
|
| SUP 5
|
| Glaxo SmithKline (GSK)
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
| |
|
|
| C 686
|
| J. Uttecht
|
| Vol #:
|
| 32
|
| |
|
|
| 2005N-0403
|
| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
|
|
|
|
|
|
|
| |
|
|
| C 96
|
| Sepracor
|
| Vol #:
|
| 10
|
| |
|
|
| C 97
|
| American Association for Homecare
|
| Vol #:
|
| 10
|
| |
|
|
| 2006E-0486
|
| Patent Extension Application for Rotateq (Rotavirus Vaccine, Live, Oral, Pentavalent), U.S. Patent No. 5,626,851
|
| |
|
|
| LET 2
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0360
|
| Determine that the discontinued formulation of Carbocaine Injection, 3% supplied in 1.8 mL cartridge was not discontinued for safety and efficacy reasons
|
| |
|
|
| LET 1
|
| FDA to Hospira, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0364
|
| Reformulation of central nervous system (CNS) stimulant drugs
|
| |
|
|
| LET 1
|
| FDA to John C. Kulli, M.D.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0371
|
| Immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market in the United States
|
|
|
|
|
|
|
| |
|
|
| LET 1
|
| FDA to Public Citizen's Health Research Group
|
| Vol #:
|
| 1
|
|
| |
|
| 2007N-0016
|
| Sentinel Network To Promote Medical Product Safety
|
| |
|
|
| EAPE 273
|
| Wallshein, Vicki
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 274
|
| Smale, Linda
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 275
|
| Chen, Ta-Jen
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 276
|
| Gund, Peter
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 277
|
| Morris, Melanie
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 278
|
| Krantz, Brian
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 279
|
| Dunn, Cindy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 280
|
| Simon, Marsha
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 281
|
| Fernandez, Danny
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 282
|
| Love, Denise
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 283
|
| Mattes, William
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 284
|
| Fisher, Harry
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 285
|
| Stephens, Sharman
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 286
|
| Albertson, Rob
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 287
|
| Frost, Alex
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 288
|
| Mosholder, Andrew
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 289
|
| Carson, Julie
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| EAPE 290
|
| Ashe, Gina
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 291
|
| Ryan, Dre
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 292
|
| Haley, Carol
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0062
|
| Determine Whether a Previously Listed Drug Eloxatin (oxaliplatin for injection) Lyophilized Powder for Infusion, 50 and 100 mg Vials Has Been Voluntarily Withdrawn From Sale for Safety or Efficacy Rea
|
|
|
|
|
|
|
| |
|
|
| CR
1
|
| FDA/DDM to Regulus Pharmaceutical Consulting, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0070
|
| Make fluoride a prescription drug for use in tooth application, tooth paste, and in bottled water
|
| |
|
|
| ACK 1
|
| FDA/DDM to Charles E. Weber
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Charles E. Weber
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0071
|
| to permit an ANDA suitability for Bisoprolol Fumarate and Hydrochlorothiazide Tablets
|
| |
|
|
| ACK 1
|
| FDA / DDM to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0072
|
| to permit an ANDA suitability for Metoprolol Tartrate Tablets
|
| |
|
|
| ACK 1
|
| FDA / DDM to Lachmman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Lachmman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0074
|
| Take specific action with respect to 21 CFR 341, the Final Monograph for Cough, Cold Allergy, Bronchodilator, Antiasthmatic Drug Products for Over-the-Counter Human Use
|
| |
|
|
| ACK 1
|
| FDA/DDM to Baltimore City Health Department
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Baltimore City Health Department et al
|
| Vol #:
|
| 1
|
|
|
