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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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5,759 rows where agency_id = "FDA" and posted_year = 2008 sorted by posted_date descending

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document_type 5

posted_year 1

  • 2008 · 5,759 ✖

agency_id 1

  • FDA · 5,759 ✖
id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2007-V-0146-0007 FDA FDA-2007-V-0146 Acknowledgement Letter to Baylor University Other ACK-Acknowledgement Letter 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2013-07-27T22:33:53Z   0 0 09000064807e13b2
FDA-1999-V-4083-0007 FDA Laser Light Show Projector FDA-1999-V-4083 FDA/CDRH Response to United Laser Artists, Inc. - Approval for Variance Other VRA-Approval for Variance 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2008-12-31T21:35:19Z   0 0 09000064807e0d82
FDA-2008-P-0343-0013 FDA FDA-2008-P-0343 Acknowledgement Letter to Novo Nordisk Inc. Other ACK-Acknowledgement Letter 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2013-07-27T22:34:25Z   0 0 09000064807f8d4b
FDA-2008-P-0411-0009 FDA FDA-2008-P-0411 Novo Nordisk Inc. - Petition for Stay of Action Other PSA-Petition for Stay 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2013-08-11T02:58:51Z   0 0 09000064807f9170
FDA-2008-P-0411-0007 FDA FDA-2008-P-0411 Novo Nordisk Inc. - Petition for Reconsideration Other PRC-Petition for Reconsideration 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2009-06-18T16:54:55Z   0 0 09000064807f8de8
FDA-2008-P-0591-0003 FDA FDA-2008-P-0591 Regulus Pharmaceutical Consulting, Inc. - Amendment to Citizen Petition Other AMD-Amendment 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2013-07-27T22:34:24Z   0 0 09000064807f25fd
FDA-2007-N-0475-0015 FDA FDA-2007-N-0475 Mylan Pharmaceuticals, Inc. (Mylan) - Letter Other LET-Letter 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2008-12-31T20:26:19Z   0 0 09000064808094ec
FDA-2008-P-0343-0011 FDA FDA-2008-P-0343 Acknowledgement Letter to Novo Nordisk Inc. Other ACK-Acknowledgement Letter 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2013-08-11T04:30:35Z   0 0 09000064807f915e
FDA-2008-P-0380-0004 FDA FDA-2008-P-0380 FDA/CDER Interim Response to National Association of Chain Drug Stores - Letter Other LET-Letter 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2013-07-27T22:34:49Z   0 0 09000064808094f2
FDA-2008-P-0343-0012 FDA FDA-2008-P-0343 Novo Nordisk Inc. - Petition for Stay of Action Other PSA-Petition for Stay 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2013-08-11T02:58:51Z   0 0 09000064807f9130
FDA-1999-V-4083-0003 FDA Laser Light Show Projector FDA-1999-V-4083 FDA/CDRH Response to United Laser Artists, Inc. - Approval for Variance Other VRA-Approval for Variance 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2008-12-31T21:35:14Z   0 0 09000064804f5ec4
FDA-1999-V-4083-0004 FDA Laser Light Show Projector FDA-1999-V-4083 United Laser Artists, Inc. Request for Extension of Compliance Date Other EXP-Request for Extension of Compliance Date 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2008-12-31T21:35:15Z   0 0 09000064804f5ec5
FDA-2008-P-0660-0001 FDA FDA-2008-P-0660 OncoTherapies Limited - Citizen Petition Other CP-Citizen Petition 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2013-07-27T22:34:18Z   0 0 09000064807eedcc
FDA-2008-P-0660-0002 FDA FDA-2008-P-0660 Acknowledgement Letter to OncoTherapies Limited Other ACK-Acknowledgement Letter 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2013-08-11T02:58:50Z   0 0 09000064807ef0e8
FDA-2008-P-0662-0002 FDA FDA-2008-P-0662 Acknowledgement Letter to Lachman Consultant Services, Inc. Other ACK-Acknowledgement Letter 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2013-08-11T04:30:38Z   0 0 09000064808080df
FDA-2007-P-0293-0004 FDA FDA-2007-P-0293 Letter from David K. Richardson to FDA DMB Other Letter(s) 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2025-03-11T18:33:37Z   0 0 09000064807df592
FDA-1999-V-4083-0005 FDA Laser Light Show Projector FDA-1999-V-4083 FDA/CDRH Response to United Laser Artists, Inc. - Approval for Variance Other VRA-Approval for Variance 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2008-12-31T21:35:16Z   0 0 09000064804f5ec6
FDA-1999-V-4083-0002 FDA Laser Light Show Projector FDA-1999-V-4083 Acknowledgement Letter to United Laser Artists, Inc. Other ACK-Acknowledgement Letter 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2008-12-31T21:35:13Z   0 0 09000064804f5ec3
FDA-2008-P-0384-0004 FDA FDA-2008-P-0384 FDA/CVM Interim Response to Laurie Rentas - Letter Other LET-Letter 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2008-12-31T20:55:39Z   0 0 09000064808094ee
FDA-2007-V-0146-0006 FDA FDA-2007-V-0146 Baylor University - Request for Extension of Compliance Date Other VAR-Application for Variance 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2008-12-31T19:03:28Z   0 0 09000064807e0b96
FDA-2007-N-0475-0009 FDA FDA-2007-N-0475 FDA/CDER/OGD - "Response to Midodrine Application Holder" - Letter Other LET-Letter 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2010-08-31T15:00:44Z   0 0 0900006480439408
FDA-2008-P-0411-0010 FDA FDA-2008-P-0411 Acknowledgement Letter to Novo Nordisk Inc. Other ACK-Acknowledgement Letter 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2013-07-28T01:58:06Z   0 0 09000064807f8e2e
FDA-2008-P-0411-0008 FDA FDA-2008-P-0411 Acknowledgement Letter to Novo Nordisk Inc. Other ACK-Acknowledgement Letter 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2013-07-27T22:34:27Z   0 0 09000064807f919e
FDA-1999-V-4083-0006 FDA Laser Light Show Projector FDA-1999-V-4083 United Laser Artists, Inc. Request for Extension of Compliance Date Other EXP-Request for Extension of Compliance Date 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2008-12-31T21:35:18Z   0 0 0900006480785a13
FDA-2008-D-0053-0158 FDA FDA-2008-D-0053 Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices Guidance for Industry Other Guidance 2008-12-31T05:00:00Z 2008 12 2020-05-13T04:00:00Z   2024-11-06T23:36:21Z   1 0 09000064845ef064
FDA-2008-P-0662-0001 FDA FDA-2008-P-0662 Lachman Consultant Services, Inc. - Citizen Petition Other CP-Citizen Petition 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2024-11-12T04:34:37Z   1 0 09000064808080cb
FDA-2008-P-0343-0010 FDA FDA-2008-P-0343 Novo Nordisk Inc. - Petition for Reconsideration Other PRC-Petition for Reconsideration 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2009-06-18T16:43:05Z   0 0 09000064807f8ce8
FDA-1999-V-4083-0001 FDA Laser Light Show Projector FDA-1999-V-4083 United Laser Artists Inc. - Request for Variance Other VAR-Application for Variance 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2008-12-31T21:35:11Z   0 0 09000064804f5ec2
FDA-2008-P-0197-0004 FDA FDA-2008-P-0197 FDA Response to William J. Kennick, Esq. - Petition Denial Other PDN-Petition Denial 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2013-07-27T22:34:19Z   0 0 09000064807eef30
FDA-2008-P-0531-0129 FDA FDA-2008-P-0531 Richard F. Edlich, M.D., Ph.D. - (University of Virginia Health System) - Supplement Citizen Petition Other SUP-Supplement 2008-12-30T05:00:00Z 2008 12 2008-12-30T05:00:00Z   2010-04-28T03:55:03Z   0 0 09000064807de339
FDA-2008-P-0605-0003 FDA FDA-2008-P-0605 Woolsthorpe Technologies - Withdrawal of Petition for Reconsideration Other WDL-Withdrawal 2008-12-30T05:00:00Z 2008 12 2008-12-30T05:00:00Z   2008-12-30T22:03:15Z   0 0 09000064807e388a
FDA-2008-P-0654-0001 FDA FDA-2008-P-0654 Procter & Gamble Company - Citizen Petition Other CP-Citizen Petition 2008-12-30T05:00:00Z 2008 12 2008-12-30T05:00:00Z   2013-07-27T22:34:02Z   0 0 09000064807e31cc
FDA-2008-P-0584-0002 FDA FDA-2008-P-0584 Acknowledgement Letter to Cohen, Tauber, Spievack & Wagner P.C. Other ACK-Acknowledgement Letter 2008-12-30T05:00:00Z 2008 12 2008-12-30T05:00:00Z   2008-12-30T16:35:33Z   0 0 09000064807a92f0
FDA-1991-P-0058-0003 FDA Amend Regulations for Food Labeling Print Size FDA-1991-P-0058 FDA/CFSAN Response to Lois M. Meyer - Letter Other LET-Letter 2008-12-30T05:00:00Z 2008 12 2008-12-30T05:00:00Z   2013-07-28T01:58:00Z   0 0 09000064807e383a
FDA-2008-N-0523-0005 FDA FDA-2008-N-0523 Plasma Protein Therapeutics Association (PPTA) - Request for Extension Comment Due Date Other EXT-Request for Extension Comment Due Date 2008-12-30T05:00:00Z 2008 12 2008-12-30T05:00:00Z   2013-07-27T22:34:14Z   0 0 09000064807e8734
FDA-2008-P-0654-0005 FDA FDA-2008-P-0654 Tab C - "FDA Response Letter to Santarus, Inc. Dated June 10, 2004" - [Proctor and Gamble - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-12-30T05:00:00Z 2008 12     2008-12-30T15:47:01Z   0 0 09000064807e323b
FDA-2008-P-0358-0007 FDA FDA-2008-P-0358 Interim Response Letter from FDA/CDER to James P. Reichmann Other Letter(s) 2008-12-30T05:00:00Z 2008 12 2008-12-30T05:00:00Z   2015-10-08T13:03:39Z   0 0 09000064807e37ba
FDA-2008-P-0368-0007 FDA FDA-2008-P-0368 FDA/CDER Interim Response to ISTA Pharmaceuticals - Letter Other LET-Letter 2008-12-30T05:00:00Z 2008 12 2008-12-30T05:00:00Z   2008-12-31T00:25:10Z   0 0 0900006480807c1c
FDA-2008-N-0650-0001 FDA FDA-2008-N-0650 Agency Information Collection Activities; Proposals, Submissions, and Approvals Notice N-Notice 2008-12-30T05:00:00Z 2008 12 2008-12-30T05:00:00Z 2009-03-03T04:59:59Z 2024-11-12T04:27:47Z E8-31058 1 0 09000064808079b5
FDA-1991-P-0058-0004 FDA Amend Regulations for Food Labeling Print Size FDA-1991-P-0058 Attachment 1 - "Wonder Stoneground 100% Whole Wheat Label" - [Lois Meyer - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-12-30T05:00:00Z 2008 12     2008-12-31T00:00:52Z   0 0 09000064807e31a3
FDA-1978-N-0018-0652 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Playtex Products, Inc. Comments to Proposed Monograph for OTC Sunscreen Products re: Comment from Energizer Personal Care (Playtex Products, Inc) Supporting & Related Material Background Material 2008-12-30T05:00:00Z 2008 12     2019-07-29T17:47:16Z   0 0 090000648055c1e1
FDA-1991-P-0058-0001 FDA Amend Regulations for Food Labeling Print Size FDA-1991-P-0058 Lois M. Meyer - Citizen Petition Other CP-Citizen Petition 2008-12-30T05:00:00Z 2008 12 2008-12-30T05:00:00Z   2013-07-28T01:42:43Z   0 0 090000648052b9b2
FDA-2008-P-0584-0001 FDA FDA-2008-P-0584 Cohen, Tauber, Spievack & Wagner P.C - Citizen Petition Other CP-Citizen Petition 2008-12-30T05:00:00Z 2008 12 2008-12-30T05:00:00Z   2011-05-12T19:39:48Z   0 0 09000064807a92d0
FDA-2008-P-0654-0002 FDA FDA-2008-P-0654 Acknowledgement Letter to Procter & Gamble Company Other ACK-Acknowledgement Letter 2008-12-30T05:00:00Z 2008 12 2008-12-30T05:00:00Z   2008-12-30T15:46:18Z   0 0 09000064807e32ef
FDA-2008-P-0654-0006 FDA FDA-2008-P-0654 Tab G - "CDER OTC Medical Officer's Review" - [Proctor & Gamble - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-12-30T05:00:00Z 2008 12     2008-12-30T15:47:02Z   0 0 09000064807e32d7
FDA-2005-P-0381-0005 FDA ANDA Suitability for Diphenoxylate Hydrochloride & Atropine Sulfate Tablets USP 5 mg/0.05.mg-CLOSED FDA-2005-P-0381 Attachment 2 - Product Description for Diphenoxylate Hydrochloride and Atropin Sulfate Tablets and Oral Solution, 5 mg/0.05 mg re Citizens Petition from Lachman Consultant Services, Inc. Supporting & Related Material Background Material 2008-12-30T05:00:00Z 2008 12     2024-11-12T17:56:32Z   0 0 09000064807ddd58
FDA-2007-N-0451-0005 FDA FDA-2007-N-0451 Agency Information Collection Activities; Proposals, Submissions, and Approvals Notice N-Notice 2008-12-30T05:00:00Z 2008 12 2008-12-30T05:00:00Z   2008-12-30T13:05:40Z E8-31057 0 0 09000064808079a6
FDA-2008-P-0654-0003 FDA FDA-2008-P-0654 Tab A - "Clinical Review: Division of Gastrointestinal and Coagulation Drug Products" - [Proctor & Gamble Company - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-12-30T05:00:00Z 2008 12     2008-12-30T15:49:04Z   0 0 09000064807e31ff
FDA-2008-P-0654-0004 FDA FDA-2008-P-0654 Tab B - "Memorandum - Director (Deputy) Summary Approval Comments NDA 21-636, Dated June 14, 2004" - [Proctor & Gamble - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-12-30T05:00:00Z 2008 12     2008-12-30T15:48:20Z   0 0 09000064807e3227
FDA-1991-P-0058-0002 FDA Amend Regulations for Food Labeling Print Size FDA-1991-P-0058 Acknowledegement Letter to Lois M. Meyer Other ACK-Acknowledgement Letter 2008-12-30T05:00:00Z 2008 12 2008-12-30T05:00:00Z   2013-07-27T22:34:01Z   0 0 09000064807e2f7c
FDA-1978-N-0018-0653 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Supplement from Energizer Personal Care (Playtex Products, Inc.) Other Supplement (SUP) 2008-12-30T05:00:00Z 2008 12 2008-12-30T05:00:00Z   2019-07-31T14:56:45Z   0 0 09000064807df3d8
FDA-2006-P-0149-0004 FDA Determine that FDA Would not Regulate as Medical Device Assays Developed by Clinical Laboratories Strictly for In-House use (Home Brew) FDA-2006-P-0149 Citizen Petition from Washington Legal Foundation (WLF) Other Citizen Petition 2008-12-30T05:00:00Z 2008 12 2008-12-30T05:00:00Z   2024-11-25T14:15:20Z   1 0 09000064804504fa
FDA-2008-N-0039-0092 FDA FDA-2008-N-0039 Freedom of Information Summary - Original Abbreviated New Drug Application - ANADA 200-459 Supporting & Related Material Freedom of Information Summary 2008-12-29T05:00:00Z 2008 12     2013-07-09T18:51:04Z   0 0 0900006480805f78
FDA-2008-N-0637-0001 FDA FDA-2008-N-0637 Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators Notice N-Notice 2008-12-29T05:00:00Z 2008 12 2008-12-29T05:00:00Z 2009-02-28T04:59:59Z 2024-11-12T04:27:44Z E8-30837 1 0 0900006480805ec3
FDA-2008-N-0652-0001 FDA FDA-2008-N-0652 Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation Notice N-Notice 2008-12-29T05:00:00Z 2008 12 2008-12-29T05:00:00Z 2009-02-28T04:59:59Z 2024-11-12T04:27:11Z E8-30839 1 0 0900006480805e3a
FDA-2008-N-0039-0091 FDA FDA-2008-N-0039 Ophthalmic and Topical Dosage Form New Animal Drugs; Triamcinolone Cream Rule Final Rule 2008-12-29T05:00:00Z 2008 12 2008-12-29T05:00:00Z   2013-07-09T18:48:19Z E8-30694 0 0 0900006480805eeb
FDA-2008-P-0647-0003 FDA FDA-2008-P-0647 Attachment 1 - Clinoril® (Sulindac, 200mg Tablets) Product Description - [Lachman Consultant Services, Inc. - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-12-24T05:00:00Z 2008 12     2008-12-24T15:06:35Z   0 0 09000064807d93bb
FDA-2008-S-0350-0002 FDA FDA-2008-S-0350 Public Submissions without Docket Number or ID Other SPE-No Docket ID 2008-12-24T05:00:00Z 2008 12 2008-12-24T05:00:00Z   2008-12-24T18:04:47Z   0 0 09000064806279a5
FDA-2005-P-0134-0004 FDA ANDA Suitability for Diphenoxylate Hydrochloride & Atropine Sulfate Oral Solution USP, 5 mg/ 0.05 mg/5 mL - CLOSED FDA-2005-P-0134 Petition Denial from FDA CDER to Lachman Consultant Services, Inc. Other PDN-Petition Denial 2008-12-24T05:00:00Z 2008 12 2008-12-24T05:00:00Z   2024-11-12T18:26:40Z   0 0 09000064807dcaef
FDA-2005-P-0134-0003 FDA ANDA Suitability for Diphenoxylate Hydrochloride & Atropine Sulfate Oral Solution USP, 5 mg/ 0.05 mg/5 mL - CLOSED FDA-2005-P-0134 Citizens Petition from Lachman Consultant Services, Inc. Other CP-Citizen Petition 2008-12-24T05:00:00Z 2008 12 2008-12-24T05:00:00Z   2024-11-12T18:24:31Z   0 0 090000648043fe1e
FDA-2006-P-0007-0022 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 See Document ID FDA-2008-D-0626-0002 re Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl Notice of Availability Reference Supporting & Related Material REF-Reference Material (external attachments) 2008-12-24T05:00:00Z 2008 12     2014-02-01T00:56:34Z   0 0 09000064807f2141
FDA-2005-P-0381-0004 FDA ANDA Suitability for Diphenoxylate Hydrochloride & Atropine Sulfate Tablets USP 5 mg/0.05.mg-CLOSED FDA-2005-P-0381 Petition Denial from FDA CDER to Lachman Consultant Services, Inc. Other PDN-Petition Denial 2008-12-24T05:00:00Z 2008 12 2008-12-24T05:00:00Z   2024-11-12T17:54:02Z   0 0 09000064807dcb48
FDA-2005-P-0134-0005 FDA ANDA Suitability for Diphenoxylate Hydrochloride & Atropine Sulfate Oral Solution USP, 5 mg/ 0.05 mg/5 mL - CLOSED FDA-2005-P-0134 Attachment 1 - Approved Drug Products with Therapeutic Equivalence Evaluations (Electronic Orange Book), April 25, 2005 re Citizens Petition from Lachman Consultant Services, Inc. Supporting & Related Material Background Material 2008-12-24T05:00:00Z 2008 12     2024-11-12T18:30:08Z   0 0 09000064807f8ef6
FDA-2008-P-0647-0004 FDA FDA-2008-P-0647 Attachment 2 - Product Description - Sulindac Capsules (Sulindac) - [Lachman Consultant Services, Inc. - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-12-24T05:00:00Z 2008 12     2008-12-24T15:06:37Z   0 0 09000064807d93dc
FDA-2008-P-0647-0005 FDA FDA-2008-P-0647 Attachment 3 - Approved Drug Products with Therapeutic Equivalence Evaluations, 28th Edition - [Lachman Consultant Services, Inc. - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-12-24T05:00:00Z 2008 12     2008-12-24T15:06:38Z   0 0 09000064807d9426
FDA-2008-S-0350-0001 FDA FDA-2008-S-0350 Food Additives Permitted in Feed and Drinking Water of Animals Rule NCR-Notice of Correction 2008-12-24T05:00:00Z 2008 12 2008-12-24T05:00:00Z   2008-12-24T17:44:31Z E8-30840 0 0 09000064807f8dc4
FDA-2008-N-0045-0008 FDA FDA-2008-N-0045 Regulatory Site Visit Training Program; December 24, 2008 Notice N-Notice 2008-12-24T05:00:00Z 2008 12 2008-12-24T05:00:00Z 2009-01-24T04:59:59Z 2010-03-26T22:43:43Z E8-30659 0 0 09000064807f8e05
FDA-2005-P-0381-0003 FDA ANDA Suitability for Diphenoxylate Hydrochloride & Atropine Sulfate Tablets USP 5 mg/0.05.mg-CLOSED FDA-2005-P-0381 Citizens Petition from Lachman Consultant Services, Inc. Other CP-Citizen Petition 2008-12-24T05:00:00Z 2008 12 2008-12-24T05:00:00Z   2024-11-12T17:52:49Z   0 0 090000648044bec6
FDA-1994-N-0182-0048 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 Transcript of the Pubic Hearing on Acyclovir - Transcript Other TR-Transcript 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2008-12-23T21:01:45Z   0 0 090000648070b75e
FDA-1994-N-0182-0009 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 FDA "Dear Colleague" Letter Other LET-Letter 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2008-12-23T21:01:01Z   0 0 090000648050714a
FDA-1994-N-0182-0027 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 Harvard Medical School - Appearance Request Other APE-Appearance Request 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2008-12-23T21:01:21Z   0 0 0900006480507164
FDA-1994-N-0182-0022 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 Association of Reproductive Professional - Supplement Other SUP-Supplement 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2008-12-23T21:01:15Z   0 0 090000648050715e
FDA-1994-N-0182-0005 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 Distribution of FR Notice for Acyclovir Public Hearing - Memorandum Other M-Memorandum 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2008-12-23T21:00:57Z   0 0 0900006480507146
FDA-1994-N-0182-0040 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 American Social Health Association - Testimony Other TS-Testimony 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2013-08-11T02:40:17Z   0 0 0900006480507187
FDA-1978-N-0018-0644 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Citizen Petition from The International Center for Technology Assessment Other Citizen Petition 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2019-07-31T18:01:58Z   0 0 090000648055a922
FDA-1978-N-0018-0648 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Acknowledgment Letter from FDA to Ciba Corporation Other Acknowledgement Letter/Receipt 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2019-07-30T16:41:18Z   0 0 09000064807d5c45
FDA-1978-N-0018-0646 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Citizen Petition from Ciba Corporation Other Citizen Petition 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2019-08-02T01:01:01Z   0 0 09000064807d5b6c
FDA-1994-N-0182-0003 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 FDA "Dear Colleague" Letter Other LET-Letter 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2008-12-23T21:00:54Z   0 0 0900006480507144
FDA-1994-N-0182-0046 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 HFD-9 - Memorandum Other M-Memorandum 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2008-12-23T21:01:43Z   0 0 09000064805071be
FDA-1994-N-0182-0013 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 Denise M. Buntin, M.D. - Appearance Request Other APE-Appearance Request 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2013-08-11T02:40:16Z   0 0 0900006480507150
FDA-1994-N-0182-0020 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 American Academy of Dermatology - Appearance Request Other APE-Appearance Request 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2013-07-27T21:20:30Z   0 0 090000648050715a
FDA-1994-N-0182-0031 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 Nonprescription Drug Manufacturers Assn. - Appearance Request Other APE-Appearance Request 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2008-12-23T21:01:26Z   0 0 090000648050716f
FDA-1994-N-0182-0030 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 Center for Disease Control and Prevention - Appearance Request Other APE-Appearance Request 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2008-12-23T21:01:25Z   0 0 090000648050716e
FDA-2004-D-0375-0019 FDA Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex FDA-2004-D-0375 Guidance for Industry and Food and Drug Administration Staff; ``Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300; Availability Notice NAD-Notice of Availability of Data 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2008-12-23T12:40:16Z E8-30586 0 0 09000064807eda05
FDA-2008-N-0644-0001 FDA FDA-2008-N-0644 SEQC--The Sequencing Quality Control Project Notice N-Notice 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2008-12-23T12:54:12Z E8-30410 0 0 09000064807eda32
FDA-1994-N-0182-0049 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 Index - List Other LST-List 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2008-12-23T21:01:47Z   0 0 090000648070b89e
FDA-1978-N-0018-0645 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Citizen Petition from Schering-Plough Corporation Other Citizen Petition 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2019-07-30T16:47:54Z   0 0 090000648055aa39
FDA-1994-N-0182-0018 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 National Women's Health Network - Appearance Request Other APE-Appearance Request 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2013-07-27T21:20:30Z   0 0 0900006480507156
FDA-1994-N-0182-0026 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 Infectious Diseases Society of America - Appearance Request Other APE-Appearance Request 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2008-12-23T21:01:20Z   0 0 0900006480507163
FDA-1994-N-0182-0007 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 Distribution of FR Notice for Acyclovir Public Hearing - Memorandum Other M-Memorandum 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2008-12-23T21:00:59Z   0 0 0900006480507148
FDA-1994-N-0182-0006 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 FDA "Dear Colleague" Letter Other LET-Letter 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2008-12-23T21:00:58Z   0 0 0900006480507147
FDA-1994-N-0182-0044 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 Harvard Medical School - Letter Other LET-Letter 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2008-12-23T21:01:41Z   0 0 09000064805071aa
FDA-1994-N-0182-0019 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 University of Kansas Medical Center - Appearance Request Other APE-Appearance Request 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2013-07-27T21:20:30Z   0 0 0900006480507157
FDA-1994-N-0182-0015 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 The Center for Proper Medication Use - Appearance Request Other APE-Appearance Request 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2013-07-27T21:20:30Z   0 0 0900006480507152
FDA-1994-N-0182-0042 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 HFD-336 - Memorandum Other M-Memorandum 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2008-12-23T21:01:39Z   0 0 0900006480507198
FDA-1994-N-0182-0017 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 University of Pittsburgh - Appearance Request Other APE-Appearance Request 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2013-07-27T21:20:30Z   0 0 0900006480507154
FDA-1994-N-0182-0032 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 Denise M. Buntin, M.D., P.C - Wthdrawal Other WDL-Withdrawal 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2013-07-27T21:20:30Z   0 0 0900006480507171
FDA-1994-N-0182-0021 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 Infectious Diseases Society for Ob-Gyn - Appearance Request Other APE-Appearance Request 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2013-07-27T21:20:30Z   0 0 090000648050715b
FDA-1994-N-0182-0033 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 HFD-9 - List Other LST-List 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2008-12-23T21:01:29Z   0 0 0900006480507173
FDA-2008-N-0648-0001 FDA FDA-2008-N-0648 Agency Information Collection Activities; Proposed Collection; Comment Request; PDUFA Pilot Project Proprietary Name Review Notice N-Notice 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z 2009-02-24T04:59:59Z 2008-12-23T12:59:23Z E8-30587 0 0 09000064807eda6f

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);