| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On October 19, 2004
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1978N-0064
|
| OTC Antiperspirant
|
|
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
|
|
| 2002P-0406
|
| ANDA Suitability for Amoxicillin & Clavulanate Potassium
|
|
|
|
|
| 2003N-0059
|
| Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach
|
|
|
|
|
| 2003P-0365
|
| Galderma product, solage containing 2% Mequinol, and 0.01% tretinoin, NDA 20-922 can be formulated as a topical solution with the substitution of Hydroquinone at 4% for the 2% mequinol as an ANDA
|
|
|
|
|
|
|
|
|
| 2003P-0441
|
| ANDA suitability for metoprolol tartrate 12.5 mg tablets
|
|
|
|
|
| 2003P-0461
|
| Abbreviation New Drug Application (ANDA) suitablility for 7.5 mg of Cyclobenzaprine HCI
|
|
|
|
|
| 2004D-0283
|
| Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
|
|
|
|
|
| 2004N-0050
|
| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Dandruff Control Ingredient
|
|
|
|
|
| 2004N-0264
|
| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
|
|
|
|
| 2004N-0267
|
| Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications
|
|
|
|
|
| 2004N-0432
|
| Radioactive Drugs for Certain Research Uses; Public Meeting
|
|
|
|
|
| 2004P-0297
|
| Nutrient Content Claim: Define Terms Low Carbohydrate, Reduced Carbohydrate and Carbohydrate Free
|
|
|
|
|
| 1978N-0064
|
| OTC Antiperspirant
|
|
|
|
|
| NEC
2
|
| FDA
|
| Vol #:
|
| 53
|
|
|
|
|
| PDN
1
|
| HFC-1 to Cosmetic, Toiletry & Fragrance Association
|
| Vol #:
|
| 53
|
|
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
|
|
| C
278
|
| Texas Veterinary Medical Diagnostic Laboratory
|
| Vol #:
|
| 99
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
|
|
| C
2037
|
| Jane Doe, Inc.
|
| Vol #:
|
| 295
|
|
|
|
|
| 2002P-0406
|
| ANDA Suitability for Amoxicillin & Clavulanate Potassium
|
|
|
|
|
| PDN
1
|
| HFD-600 to The Weinberg Group Inc.
|
| Vol #:
|
| 2
|
|
|
|
|
| 2003N-0059
|
| Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach
|
|
|
|
|
| C
4
|
| International Assn for Pharmaceutical Science and Technology (PDA)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0365
|
| Galderma product, solage containing 2% Mequinol, and 0.01% tretinoin, NDA 20-922 can be formulated as a topical solution with the substitution of Hydroquinone at 4% for the 2% mequinol as an ANDA
|
|
|
|
|
|
|
|
|
|
|
| PDN
1
|
| HFD-600 to Jerussi Consulting, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0441
|
| ANDA suitability for metoprolol tartrate 12.5 mg tablets
|
|
|
|
|
| PDN
1
|
| HFD-600 to Nabeal M. Saif, R.Ph.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0461
|
| Abbreviation New Drug Application (ANDA) suitablility for 7.5 mg of Cyclobenzaprine HCI
|
|
| | | | | | | | |
|
|
|
|
| PAV
1
|
| HFD-600 to Anabolic Laboratories, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0283
|
| Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
|
|
|
|
|
| C
1
|
| Animal Health Institute (AHI)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0050
|
| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Dandruff Control Ingredient
|
|
|
|
|
| LET 4
|
| Number not used
|
| Vol #:
|
| 3
|
|
|
|
|
| LET
5
|
| Procter & Gamble Company
|
| Vol #:
|
| 2
|
|
|
|
|
| LET 6
|
| Number not used
|
| Vol #:
|
| 9
|
|
|
|
|
| MT
1
|
| memo of telephone conversation between Keith Olin,Michael Koenig and Frederick (Rick) Stearns
|
| Vol #:
|
| 3
|
|
|
|
|
| MT
2
|
| memo of telephone conversation between Keith Olin,Michael Koening and Elizabeth Finn
|
| Vol #:
|
| 9
|
|
|
|
|
| RPT
1
|
| Clariant GmbH
|
| Vol #:
|
| 3
|
|
|
|
|
| RPT
2
|
| Procter and Gamble Company
|
| Vol #:
|
| 9
|
|
|
|
|
| 2004N-0264
|
| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
|
|
|
|
| C 192
|
| E. Marney
|
| Vol #:
|
| 23
|
|
|
|
|
| 2004N-0267
|
| Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications
|
|
|
|
|
| C
4
|
| Advanced Medical Technology Assn (AdvaMed)
|
| Vol #:
|
| 1
|
|
|
|
|
| C
5
|
| Bristol-Myers Squibb Company
|
| Vol #:
|
| 1
|
|
|
|
|
| C
6
|
| Wyeth Pharmaceuticals
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0432
|
| Radioactive Drugs for Certain Research Uses; Public Meeting
|
|
|
|
|
| APE 1
|
| Xceleron Ltd
|
| Vol #:
|
| 1
|
|
|
|
|
| APE 2
|
| Columbia University
|
| Vol #:
|
| 1
|
|
|
|
|
| APE 3
|
| University of Tennessee Medical Center
|
| Vol #:
|
| 1
|
|
|
|
|
| APE 4
|
| University of St Louis, Children's Hospital, American College of Nuclear Physicians, Society of Nucl
|
| Vol #:
|
| 1
|
|
|
|
|
| APE 5
|
| University of Tennessee Medical Center
|
| Vol #:
|
| 1
|
|
|
|
|
| APE 6
|
| University of Tennessee Medical Center
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0297
|
| Nutrient Content Claim: Define Terms Low Carbohydrate, Reduced Carbohydrate and Carbohydrate Free
|
|
|
|
|
| LET
1
|
| Center for Science in the Public Interest (CSPI)
|
| Vol #:
|
| 1
|
|
