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| Dockets Entered
On October 11, 2005
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2000N-0504
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| Egg Safety Action Plan
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| 2004N-0289
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| Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter
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| 2004N-0526
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| Agency Information Collection Activities; Proposed Collection; Comment Request;
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| 2004P-0074
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| oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
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| 2005D-0401
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| Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended Prominent and Conspicuous Mark of Manufacturers on Single-Us
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| 2005N-0083
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| Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics
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| 2005N-0124
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of
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| 2005N-0217
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Product Voluntary Reporting Program
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| 2005P-0352
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| bioequivalence criteria be applied separately to oxybutynin and its active metabolite, desethyloxbutynin
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16620
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| Ortho Molecular Products
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| Vol #:
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| 149
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| LET
16621
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| Ortho Molecular Products
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| Vol #:
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| 149
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| LET
16622
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| Ortho Molecular Products
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| Vol #:
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| 149
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| LET
16623
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| Ortho Molecular Products
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| Vol #:
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| 149
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| LET
16624
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| Ortho Molecular Products
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| Vol #:
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| 149
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| LET
16625
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| Ortho Molecular Products
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| Vol #:
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| 149
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| LET
16626
Attachment
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| Ortho Molecular Products
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| Vol #:
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| 149
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| LET
16627
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| Adeeva Nutritionals Canada Inc.
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| Vol #:
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| 149
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| LET
16628
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| Enzymatic Therapy
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| Vol #:
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| 149
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| LET
16629
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| Enzymatic Therapy
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| Vol #:
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| 149
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| LET
16630
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| Enzymatic Therapy
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| Vol #:
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| 149
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| LET
16631
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| Pharmanex, LLC
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| Vol #:
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| 149
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| 2000N-0504
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| Egg Safety Action Plan
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| C
386
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| Center for Science in the Public Interest
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| Vol #:
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| 32
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| EMC 17
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| Form Letter count
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| Vol #:
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| 15
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| CR
1
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| Amphastar Pharmaceuticals, Inc.
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| Vol #:
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| 6
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| 2004N-0289
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| Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter
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| NFR
1
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| FDA
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| Vol #:
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| 1
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| 2004N-0526
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| Agency Information Collection Activities; Proposed Collection; Comment Request;
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| SS
1
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| Supporting Statement
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| Vol #:
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| 1
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| 2004P-0074
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| oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
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| C
5
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| Savient Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2005D-0401
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| Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended Prominent and Conspicuous Mark of Manufacturers on Single-Us
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| GDL
1
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| Guidance
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2005N-0083
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| Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| SS
1
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| Supporting Statement
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| Vol #:
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| 1
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| 2005N-0124
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| SS
1
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| Supporting Statement
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| Vol #:
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| 1
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| 2005N-0217
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Product Voluntary Reporting Program
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| N
2
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| FDA
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| Vol #:
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| 1
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| C
60
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| Planned Parenthood of Metropolitan New Jersey Inc
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| Vol #:
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| 9
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| C
61
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| Family Planning Advocates of New York State
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| Vol #:
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| 9
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| C 62
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| S Dickhaus
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| Vol #:
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| 9
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| C 63
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| S & E Milam
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| Vol #:
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| 9
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| C 64
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| K L Ponto MD
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| Vol #:
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| 9
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| C 65
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| F M Schaf et al
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| Vol #:
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| 9
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| C 66
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| W & N Poole
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| Vol #:
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| 9
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| 2005P-0352
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| bioequivalence criteria be applied separately to oxybutynin and its active metabolite, desethyloxbutynin
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| SUP
1
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| Ortho-McNeil Pharmaceutical, Inc.
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| Vol #:
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| 3
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