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Dockets Management
Dockets Entered On November 4, 2005
Table of Contents
Docket # Title
1976N-0052G OTC general comments & combinations
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1999P-0796 Stay the effective date of approval of ANDAs for Diprivan
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
2005N-0345 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
2005P-0076 OxyContin and Paladone removal from market and label changes limiting indications to severe chronic pain
2005P-0116 To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
2005P-0397 Classification of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Mutation Detection System
2005P-0430 Requests that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act.
1976N-0052G OTC general comments & combinations
C 231 Bayer Healthcare, LLC Vol #: 38
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 16783 Ajinomoto USA, Inc. Vol #: 151
LET 16784 Ajinomoto USA Inc. Vol #: 151
LET 16785 Ajinomoto USA Inc. Vol #: 151
LET 16786 Ajinomoto USA Inc. Vol #: 151
LET 16787 Boots Retail USA Inc. Vol #: 151
LET 16788 Boots Retail USA Inc. Vol #: 151
LET 16789 Boots Retail USA Inc. Vol #: 151
LET 16790 Ajinomoto USA Inc. Vol #: 151
LET 16791 Univera, Inc., d.b.a. Oasis LifeSciences Vol #: 151
LET 16792 Enzymatic Therapy Vol #: 151
LET 16793 Enzymatic Therapy Vol #: 151
LET 16794 Enzymatic Therapy Vol #: 151
LET 16795 Enzyamtic Therapy Vol #: 151
LET 16796 Enzymatic Therapy Vol #: 151
LET 16797 Herbalife International of America, Inc. Vol #: 151
1999P-0796 Stay the effective date of approval of ANDAs for Diprivan
WDL 1 AstraZeneca Pharmaceuticals, LP Vol #: 1
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
C 664 A. Hamburk Vol #: 23
C 665 Center for Science in the Public Interest (CSPI) Vol #: 23
2005N-0345 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
ANS 45 HFW-1 to Honorable Maurice D. Hinchey Vol #: 99
ANS 46 HFW-1 to Honorable Jane Harman Vol #: 99
ANS 47 HFW-1 to Honorable Luis V. Gutierrez Vol #: 99
ANS 48 HFW-1 to Honorable Raul M. Grijalva Vol #: 99
ANS 49 HFW-1 to Honorable Sam Farr Vol #: 99
ANS 50 HFW-1 to Honorable Anne G. Eshoo Vol #: 99
ANS 51 HFW-1 to Honorable William D. Delahunt Vol #: 99
ANS 52 HFW-1 to Honorable Peter A. DeFazio Vol #: 99
ANS 53 HFW-1 to Honorable Susan A. Davis Vol #: 99
ANS 54 HFW-1 to Honorable Elijah E. Cummings Vol #: 99
ANS 55 HFW-1 to Honorable Julia M. Carson Vol #: 99
ANS 56 HFW-1 to Honorable Russ Carnahan Vol #: 99
ANS 57 HFW-1 to Honorable Michael E. Capuano Vol #: 99
ANS 58 HFW-1 to Honorable Lois Capps Vol #: 99
ANS 59 HFW-1 to Honorable Sherrod Brown Vol #: 99
ANS 60 HFW-1 to Honorable Earl Blumenauer Vol #: 99
ANS 61 HFW-1 to Honorable Tammy Baldwin Vol #: 99
ANS 62 HFW-1 to Honorable Louise M. Slaughter Vol #: 99
ANS 63 HFW-1 to Honorable Tom Lantos Vol #: 99
ANS 64 HFW-1 to Honorable Diana DeGette Vol #: 99
ANS 65 HFW-1 to Honorable Rosa L. DeLauro Vol #: 99
ANS 66 HFW-1 to Honorable Judy Biggert Vol #: 99
ANS 67 HFW-1 to Honorable Sherwood L. Boehlert Vol #: 99
ANS 68 HFW-1 to Honorable Nancy L. Johnson Vol #: 99
ANS 69 HFW-1 to Honorable Joe Baca Vol #: 99
ANS 70 HFW-1 to Honorable Thomas H. Allen Vol #: 99
ANS 71 HFW-1 to Honorable Neil Abercrombie Vol #: 99
ANS 72 HFW-1 to Honorable Christopher Shays Vol #: 99
ANS 73 HFW-1 to Honorable Henry A. Waxman Vol #: 99
ANS 74 HFW-1 to Honorable Mark Steven Kirk Vol #: 99
ANS 75 HFW-1 to Honorable Nita M. Lowey Vol #: 99
C 448 Ibis Reproductive Health Vol #: 99
C 449 National Asian Pacific American Women's Forum (NAPAWF) Vol #: 99
C 450 American Civil Liberties Union (ACLU) Vol #: 99
C 451 C. Dixon Vol #: 99
C 452 Mr and Mrs A. Durkin Vol #: 99
C 453 Aventis Pharmaceuticals, Inc and Sanofi-Synthelabo, Inc. Vol #: 99
C 454 Bipartisan Congressional Pro-Choice Caucus Vol #: 99
REF 1 Reference Vol #: 99
2005P-0076 OxyContin and Paladone removal from market and label changes limiting indications to severe chronic pain
RC 2 Dr. Stephen G. Gelfand Vol #: 1
2005P-0116 To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
C 5
Attachments
National Women's Health Network Vol #: 2
2005P-0397 Classification of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Mutation Detection System
CP 1 Tm Bioscience Corporation Vol #: 1
2005P-0430 Requests that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act.
SUP 1 G. Skipper. M. D. Vol #: 2

Page created on November 17, 2005 RSC

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