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