| | | | | |
|
|
|
|
| Dockets Entered
On March 2, 2007
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1987P-0335
|
| TRIAMTERENE 50MG & HYDROCHLOROTHIAZIDE 25MG ANDA SUIT
|
|
|
|
|
| 1987P-0340
|
| NIFEDIPINE 10 MG AND 20 MG TABLETS
|
|
|
|
|
| 1987P-0367
|
| ANDA SUITABILITY RE: STERILE PHENYTOIN SODIUM 100 & 250
|
|
|
|
|
| 1987P-0399
|
| ANDA FOR PROPRANOLOL HCL/HYDROCHLOROTHIAZIDE 40/25 80/25
|
|
|
|
|
| 1988P-0011
|
| CYCLOPHOSPHAMIDE FOR INJECTION RECONSTITUTED & REPACKAGED
|
|
|
|
|
| 1988P-0036
|
| ANDA SUITABILITY RE: CHLORHEXIDINE GLUCONATE
|
|
|
|
|
| 1988P-0061
|
| HYDROCODONE BITARTRATE & HOMATROPINE METHYLBROMIDE SYRUP
|
|
|
|
|
| 1988P-0149
|
| LEUCOVORIN CALCIUM ORAL SOLUTION, 1 MG PER ML FOR ANDA
|
|
|
|
|
| 1988P-0277
|
| Quinidine Sulfate Extended-Release Capsules for ANDA
|
|
|
|
|
| 1988P-0350
|
| ANDA for Clemastine Fumarate/Phenylpropanolamine Hydrochlori
|
|
|
|
|
| 1988P-0379
|
| REPACKAGED CYCLOPHOSPHAMIDE FOR INJECTION ANDA SUITABILIT
|
|
|
|
|
| 1988P-0391
|
| ANDA SUITABILITY FOR PREDNISONE CAPSULES
|
|
|
|
|
| 1989P-0028
|
| ANDA SUIT TOPICAL LOTION 0.2% HYDROCORTISONE VALERATE 2MG
|
|
|
|
|
| 1989P-0029
|
| ANDA SUIT TOPICAL SOLUTION 0.2% HYDROCORTISONE/VALERATE 2
|
|
|
|
|
| 1989P-0071
|
| MORPHINE SULFATE IN CAPSULE FORM ANDA SUITABILITY
|
|
|
|
|
| 1989P-0399
|
| ANDA Suitability re: Carbamazepine Suspension 200 mg/5 ml
|
|
|
|
|
| 1989P-0435
|
| Pentamidine Isethionate Sterile Nonpyrogenic Inject for ANDA
|
|
|
|
|
| 1990P-0049
|
| ANDA Suitability for Hydrocortisone Acetate
|
|
|
|
|
| 1990P-0154
|
| ANDA suitable for topical ointment containing Hydrocortisone
|
|
|
|
|
| 1990P-0198
|
| ANDA for lotion dosage form of Clobetasol Propionate 0.05%
|
|
|
|
|
| 1990P-0436
|
| ANDA Suitability Petition for Nifidepine extended release
|
|
|
|
|
| 1991P-0348
|
| ANDA Suitability for Albuterol Sulfate Capsules - 4 mg base
|
|
|
|
|
| 1992P-0048
|
| ANDA Suitability Petition for Triazolam Intensol (Halcion)
|
|
|
|
|
| 1992P-0101
|
| ANDA suitability for topical foam dosage of hydrocortisone
|
|
|
|
|
| 1992P-0282
|
| ANDA to include drug Acetaminophen Aspirin
|
|
|
|
|
| 1992P-0335
|
| ANDA Suit 2mg/4mg Scored Chewable Albuterol Sulfate Tablet
|
|
|
|
|
| 1992P-0336
|
| ANDA Suite 5mg & 10mg Scored Prednisone Chewable Tablet
|
|
|
|
|
| 1995P-0223
|
| ANDA Suit for Hydrocortisone Butyrate Topical Creamy Lotion
|
|
|
|
|
| 1995P-0268
|
| ANDA Suitability for Acyclovir Sodium Ready-to Use Infusion
|
|
|
|
|
| 1995P-0277
|
| ANDA Suitability Cholestyramine chewable tablet
|
|
|
|
|
| 1995P-0279
|
| ANDA for Butalbital, Acetaminophen, Caffeine and Hydrocodone
|
|
|
|
|
| 1995P-0326
|
| ANDA for Nifedipine Extended-release Capsules
|
|
|
|
|
| 1995P-0328
|
| ANDA Suitability for Metronidazole in Topical Lotion
|
|
|
|
|
| 1996P-0018
|
| ANDA for Potassium Chloride Extended-release Microparticle
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| 2000D-1598
|
| Voluntary Labeling for Bioengineered Foods
|
|
|
|
|
| 2003N-0324
|
| New Animal Drugs; Removal of Obsolete and Redundant Regulations
|
|
| | | | | | | | |
|
| |
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
|
|
|
|
| 2005N-0262
|
| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
|
|
|
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
|
|
|
|
| 2005N-0373
|
| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
|
|
|
|
|
| 2005P-0384
|
| Deficient Peripheral Metabolism of Thyroxine to Triiodothyronine
|
|
|
|
|
| 2006D-0336
|
| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
|
|
|
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
|
|
|
|
| 2006N-0061
|
| Charging for Investigational Drugs
|
|
|
|
|
| 2006N-0062
|
| Expanded Access to Investigational Drugs for Treatment Use
|
|
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
|
|
| 2007N-0005
|
| Prescription Drug User Fee Act (PDUFA): Public Meeting
|
|
|
|
|
| 2007P-0076
|
| ANDA Suitability for Promethazine Hydrochloride and Hydrocodone Bitartrate Syrup, 6.25 mg/2.5 mg per 5 mL and 6.25 mg/1.67 mg per 5 mL
|
|
|
|
|
| 2007V-0075
|
| Laser Light Show
|
|
| |
|
| 1987P-0335
|
| TRIAMTERENE 50MG & HYDROCHLOROTHIAZIDE 25MG ANDA SUIT
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 1987P-0340
|
| NIFEDIPINE 10 MG AND 20 MG TABLETS
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1987P-0367
|
| ANDA SUITABILITY RE: STERILE PHENYTOIN SODIUM 100 & 250
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1987P-0399
|
| ANDA FOR PROPRANOLOL HCL/HYDROCHLOROTHIAZIDE 40/25 80/25
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1988P-0011
|
| CYCLOPHOSPHAMIDE FOR INJECTION RECONSTITUTED & REPACKAGED
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1988P-0036
|
| ANDA SUITABILITY RE: CHLORHEXIDINE GLUCONATE
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1988P-0061
|
| HYDROCODONE BITARTRATE & HOMATROPINE METHYLBROMIDE SYRUP
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1988P-0149
|
| LEUCOVORIN CALCIUM ORAL SOLUTION, 1 MG PER ML FOR ANDA
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 1988P-0277
|
| Quinidine Sulfate Extended-Release Capsules for ANDA
|
|
| | | | | | | | |
|
| |
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1988P-0350
|
| ANDA for Clemastine Fumarate/Phenylpropanolamine Hydrochlori
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 1988P-0379
|
| REPACKAGED CYCLOPHOSPHAMIDE FOR INJECTION ANDA SUITABILIT
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1988P-0391
|
| ANDA SUITABILITY FOR PREDNISONE CAPSULES
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1989P-0028
|
| ANDA SUIT TOPICAL LOTION 0.2% HYDROCORTISONE VALERATE 2MG
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1989P-0029
|
| ANDA SUIT TOPICAL SOLUTION 0.2% HYDROCORTISONE/VALERATE 2
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1989P-0071
|
| MORPHINE SULFATE IN CAPSULE FORM ANDA SUITABILITY
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1989P-0399
|
| ANDA Suitability re: Carbamazepine Suspension 200 mg/5 ml
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1989P-0435
|
| Pentamidine Isethionate Sterile Nonpyrogenic Inject for ANDA
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 1990P-0049
|
| ANDA Suitability for Hydrocortisone Acetate
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| NWL 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1990P-0154
|
| ANDA suitable for topical ointment containing Hydrocortisone
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1990P-0198
|
| ANDA for lotion dosage form of Clobetasol Propionate 0.05%
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1990P-0436
|
| ANDA Suitability Petition for Nifidepine extended release
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1991P-0348
|
| ANDA Suitability for Albuterol Sulfate Capsules - 4 mg base
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1992P-0048
|
| ANDA Suitability Petition for Triazolam Intensol (Halcion)
|
|
| | | | | | | | |
|
| |
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1992P-0101
|
| ANDA suitability for topical foam dosage of hydrocortisone
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 1992P-0282
|
| ANDA to include drug Acetaminophen Aspirin
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1992P-0335
|
| ANDA Suit 2mg/4mg Scored Chewable Albuterol Sulfate Tablet
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1992P-0336
|
| ANDA Suite 5mg & 10mg Scored Prednisone Chewable Tablet
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1995P-0223
|
| ANDA Suit for Hydrocortisone Butyrate Topical Creamy Lotion
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1995P-0268
|
| ANDA Suitability for Acyclovir Sodium Ready-to Use Infusion
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1995P-0277
|
| ANDA Suitability Cholestyramine chewable tablet
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1995P-0279
|
| ANDA for Butalbital, Acetaminophen, Caffeine and Hydrocodone
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 1995P-0326
|
| ANDA for Nifedipine Extended-release Capsules
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1995P-0328
|
| ANDA Suitability for Metronidazole in Topical Lotion
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1996P-0018
|
| ANDA for Potassium Chloride Extended-release Microparticle
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| LET 19169
|
| Bayer HealthCare LLC
|
| Vol #:
|
| 171
|
|
|
|
|
| LET 19170
|
| Bayer HealthCare LLC
|
| Vol #:
|
| 171
|
|
|
|
|
| LET 19171
|
| Pure Encapsulations, Inc.
|
| Vol #:
|
| 171
|
|
|
|
|
| LET 19172
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 171
|
|
|
|
|
| LET 19173
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 171
|
|
| | | | | | | | |
|
| |
|
| LET 19174
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 171
|
|
|
|
|
| LET 19175
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 171
|
|
|
|
|
| LET 19176
|
| Erostra, LLC
|
| Vol #:
|
| 171
|
|
|
|
|
| LET 19177
|
| ITV Global, Inc.
|
| Vol #:
|
| 171
|
|
|
|
|
| LET 19178
|
| Metagenics, Inc.
|
| Vol #:
|
| 171
|
|
|
|
|
| LET 19179
|
| Waiora International, Inc.
|
| Vol #:
|
| 171
|
|
|
|
|
| LET 19180
|
| Planetary Herbals
|
| Vol #:
|
| 172
|
|
|
|
|
| LET 19181
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
|
|
|
|
| LET 19182
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
|
|
|
|
| LET 19183
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
|
|
|
|
| LET 19184
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
|
|
|
|
| LET 19185
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
|
|
|
|
| LET 19186
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
|
|
|
|
| LET 19187
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
|
|
|
|
| LET 19188
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
|
|
|
|
| LET 19189
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
|
|
|
|
| LET 19190
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
|
|
|
|
| LET 19191
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
|
|
|
|
| LET 19192
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
|
|
|
|
| LET 19193
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
|
|
|
|
| LET 19194
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
|
|
|
|
| 2000D-1598
|
| Voluntary Labeling for Bioengineered Foods
|
|
|
|
|
| ANS 2
|
| FDA/CFSAN to Kasia Ciaston
|
| Vol #:
|
| 580
|
|
|
|
|
| C 10017
|
| R. & J. DeFilipi
|
| Vol #:
|
| 580
|
|
|
|
|
| 2003N-0324
|
| New Animal Drugs; Removal of Obsolete and Redundant Regulations
|
|
|
|
|
| WDL 1
|
| Pennfield Oil Co./Pennfield Animal Health Co.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
|
|
|
|
| C 276
|
| L.C. Robertson
|
| Vol #:
|
| 22
|
|
|
|
|
| 2005N-0262
|
| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
|
|
|
|
|
| LET 14
|
| Bristol-Myers Squibb Co.
|
| Vol #:
|
| 1
|
|
| |
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
|
|
|
|
| EC 1658
|
| Mrs. Brenda Kemp
|
| Vol #:
|
| 31
|
|
|
|
|
| EC 1659
|
| Mrs. Nancy Blender
|
| Vol #:
|
| 31
|
|
|
|
|
| EC 1660
|
| Friedman School of Nutrition, Tufts University
|
| Vol #:
|
| 31
|
|
| | | | | | | | |
|
| |
|
| 2005N-0373
|
| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
|
|
|
|
|
| C 1
|
| GlaxoSmithKline
|
| Vol #:
|
| 1
|
|
|
|
|
| C 2
|
| T. Tiedt
|
| Vol #:
|
| 1
|
|
|
|
|
| C 3
|
| Sanofi-Aventis U. S., Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| EXT 1
|
| Advanced Medical Technology Association (AdvaMed)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0384
|
| Deficient Peripheral Metabolism of Thyroxine to Triiodothyronine
|
|
|
|
|
| C 2
|
| E. Pritchard
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0336
|
| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
|
|
|
|
|
| C 6
|
| Clinical Laboratory Management Association (CLMA)
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 12
|
| American College of Medical Genetics
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 13
|
| Invitrogen Corporation
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 14
|
| Cepheid
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
|
|
|
|
| C 6
|
| American Clinical Laboratory Association
|
| Vol #:
|
| 1
|
|
|
|
|
| C 7
|
| H. Schiff
|
| Vol #:
|
| 1
|
|
|
|
|
| C 8
|
| Clinical Laboratory Management Association (CLMA)
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 25
|
| College of American Pathologists
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 26
|
| Ms. Mary Barry
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 27
|
| breast cancer advocate, Center for Medical Consume
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 28
|
| Baylor University Medical Center
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 29
|
| American College of Medical Genetics
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 30
|
| BioSignia, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 31
|
| ASCO
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 32
|
| Invitrogen Corporation
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 33
|
| Cepheid
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0061
|
| Charging for Investigational Drugs
|
|
|
|
|
| C 5
|
| University of Minnesota
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0062
|
| Expanded Access to Investigational Drugs for Treatment Use
|
|
|
|
|
| C 6
|
| J. Benham
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
|
|
| C 61
|
| S. Powers
|
| Vol #:
|
| 6
|
|
|
|
|
| C 62
|
| S. Seeley
|
| Vol #:
|
| 6
|
|
|
|
|
| 2007N-0005
|
| Prescription Drug User Fee Act (PDUFA): Public Meeting
|
|
