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| Dockets Entered
On October 1, 2003
Table of Contents
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| Docket #
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| Title
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
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| 1998P-0070
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| Refrain from Approving PMAs for Stem Cell Separation System
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2000N-1484
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| Safety Reporting Requirements Human Drug/Biological Products
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| 2000P-0685
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| Revise of Yogurt Standards
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| 2002P-0089
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| Allow Electronic Labeling to Meet 201(m) of FD&C Act
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| 2003D-0226
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| Compliance with Sec 301 of the Medical Device User Fee and Modernization Act of 2002 b Identification of Manufacturer of Medical Devices; Availability
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| 2003N-0143
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| Continued Over-the-Counter Status of Ipecac Syrup
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| 2003N-0268
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations in Manufacturing
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| 2003N-0338
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| Secretary's Roundtable on Obesity/Nutrition
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| 2003P-0279
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| Abbreviated New Drug Application for a Topical solution of the three actives fluocinolone acetonide, hydroquinone, and tretinoin
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| 2003P-0291
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| Enforce the law and prevent unlaw sale of contact lens
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| 2003P-0460
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| ANDA Suitability 200 mg Carisoprodol and 325 mg of Acetaminophen combination drug product ; 200 mg Carisprodol, 325 mg Acetaminophen, and 16 mg Codeine Phosphate drug product
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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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| 2003V-0459
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| Laser Light Show
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
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| C
249
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| Apothecary, Inc.
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| Vol #:
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| 41
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| 1998P-0070
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| Refrain from Approving PMAs for Stem Cell Separation System
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| C 2
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| Form Letter Count
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| 2
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| C 756
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| Cary Terrall
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| Vol #:
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| 21
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| 2000N-1484
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| Safety Reporting Requirements Human Drug/Biological Products
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| C
7
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| PPD Medical Communications
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| Vol #:
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| 3
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| 2000P-0685
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| Revise of Yogurt Standards
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| C 9
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| GRUPO LECHE PASCUAL
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| 1
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| 2002P-0089
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| Allow Electronic Labeling to Meet 201(m) of FD&C Act
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| PAV
1
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| HFZ-1 to St. Jude Medical, CRMD
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| Vol #:
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| 1
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| 2003D-0226
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| Compliance with Sec 301 of the Medical Device User Fee and Modernization Act of 2002 b Identification of Manufacturer of Medical Devices; Availability
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| C
5
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| Dental Trade Alliance (DTA)
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| Vol #:
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| 1
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| 2003N-0143
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| Continued Over-the-Counter Status of Ipecac Syrup
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| LET
1
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| HFD-560 to American Assn of Poison Control Centers
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| Vol #:
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| 1
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| 2003N-0268
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations in Manufacturing
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| C
1
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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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| 2003N-0338
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| Secretary's Roundtable on Obesity/Nutrition
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| EMC
3
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| St Joseph's University
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| Vol #:
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| 1
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| EMC
4
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| American Dietetic Association
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| Vol #:
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| 1
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| EMC
5
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| American Obesity Association
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| Vol #:
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| 1
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| EMC
6
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| Louis Aronne, MD et al
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| Vol #:
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| 1
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| 2003P-0279
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| Abbreviated New Drug Application for a Topical solution of the three actives fluocinolone acetonide, hydroquinone, and tretinoin
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| C
1
Attachment
1, 2
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| Hill Dermaceuticals, Inc.
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| Vol #:
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| 1
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| 2003P-0291
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| Enforce the law and prevent unlaw sale of contact lens
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| C 52
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| Craig R. Swanson, O.D.
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| Vol #:
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| 1
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| C 53
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| Roger A. Moore, O.D.
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| Vol #:
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| 1
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| C 54
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| Karl J. Kleinau, O.D.
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| Vol #:
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| 1
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| C 55
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| Michael J. Onyon, O.D.
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| Vol #:
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| 1
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| 2003P-0460
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| ANDA Suitability 200 mg Carisoprodol and 325 mg of Acetaminophen combination drug product ; 200 mg Carisprodol, 325 mg Acetaminophen, and 16 mg Codeine Phosphate drug product
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| ACK 1
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| HFA-305 to Anabolic Laboratories, Inc.
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| Vol #:
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| 1
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| ACK 2
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| Number not used
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| Vol #:
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| 1
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| CP
1
Attachment
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| Anabolic Laboratories, Inc.
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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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| ACK
1
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| HFA-305 to Anabolic Laboraties Inc.
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| Vol #:
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| 1
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| ACK 2
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| Number not used
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| Vol #:
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| 1
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| CP
1
Attachment
1, 2
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| Anabolic Laboratories, Inc.
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| Vol #:
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| 1
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| 2003V-0459
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| Laser Light Show
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| ACK
1
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| HFA-305 to NEA Inc.
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| Vol #:
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| 1
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| VAR
1
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| NEA Inc.
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| Vol #:
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| 1
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