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withdrawn,object_id FDA-1992-N-0007-0004,FDA,FDA-1992-N-0007,FDA,Notice,NAD-Notice of Availability of Data,1997-12-02T05:00:00Z,1997,12,,,2008-05-16T23:31:45Z,,0,0,0900006480525bec FDA-1996-N-0052-0001,FDA,FDA-1996-N-0052,FDA,Notice,NFR-Notice of Final Rule,1997-11-28T05:00:00Z,1997,11,,,2008-05-16T22:17:40Z,,0,0,09000064804fd270 FDA-1997-M-0021-0003,FDA,FDA-1997-M-0021,"Background Material re Ventritex, Inc.; Premarket Approval of the TVL® Lead System",Notice,Notice of Approval,1997-11-20T05:00:00Z,1997,11,1997-11-20T05:00:00Z,1997-12-20T04:59:59Z,2024-11-27T13:22:23Z,,0,0,09000064805ca10b FDA-1997-M-0021-0002,FDA,FDA-1997-M-0021,"Background Material re Ventritex, Inc.; Premarket Approval of the TVL® Lead System",Notice,Notice of Approval,1997-11-20T05:00:00Z,1997,11,1997-11-20T05:00:00Z,1997-12-20T04:59:59Z,2024-11-27T13:21:44Z,,0,0,09000064805ca109 FDA-1997-M-0021-0001,FDA,FDA-1997-M-0021,"Ventritex, Inc.; Premarket Approval of the TVL® Lead System",Notice,Notice of Approval,1997-11-20T05:00:00Z,1997,11,1997-11-20T05:00:00Z,1997-12-20T04:59:59Z,2024-11-27T13:20:25Z,,0,0,09000064805ca107 FDA-1993-N-0043-0005,FDA,FDA-1993-N-0043,(COPY)- Expedited Safety Reporting Requirements for Human Drug and Biological Products,Notice,Notice of Final Rule,1997-10-09T04:00:00Z,1997,10,1997-10-09T04:00:00Z,1997-12-09T04:59:59Z,2024-04-29T15:09:23Z,,0,0,09000064804fc456 FDA-1993-N-0043-0006,FDA,FDA-1993-N-0043,(COPY)- Expedited Safety Reporting Requirements for Human Drug and Biological Products,Notice,Notice of Final Rule,1997-10-09T04:00:00Z,1997,10,1997-10-09T04:00:00Z,1997-12-09T04:59:59Z,2024-04-29T15:10:12Z,,0,0,09000064804fc457 FDA-1993-N-0043-0004,FDA,FDA-1993-N-0043,Expedited Safety Reporting Requirements for Human Drug and Biological Products,Notice,Notice of Final Rule,1997-10-09T04:00:00Z,1997,10,1997-10-09T04:00:00Z,1997-12-09T04:59:59Z,2024-04-29T15:08:44Z,,0,0,09000064804fc455 FDA-1995-N-0054-0003,FDA,FDA-1995-N-0054,FDA,Notice,NEC-Notice of Extension,1997-09-17T04:00:00Z,1997,9,1997-09-17T04:00:00Z,1997-12-03T04:59:59Z,2008-05-16T22:28:01Z,,0,0,0900006480563bb8 FDA-1991-F-0039-0001,FDA,FDA-1991-F-0039,Goldschmidt A. G.,Notice,NWL-Notice of Withdrawl,1997-09-12T04:00:00Z,1997,9,,,2008-05-16T23:37:58Z,,0,0,090000648052a0c0 FDA-1989-N-0019-0002,FDA,FDA-1989-N-0019,"References from Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Addition of ""Geriatric Use"" Subsection in the Labeling",Notice,Notice of Final Rule,1997-08-28T04:00:00Z,1997,8,1997-08-28T04:00:00Z,1997-10-30T04:59:59Z,2024-01-16T20:19:42Z,,0,0,09000064804757c4 FDA-1989-N-0019-0001,FDA,FDA-1989-N-0019,"Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Addition of ""Geriatric Use"" Subsection in the Labeling",Notice,Notice of Final Rule,1997-08-28T04:00:00Z,1997,8,1997-08-28T04:00:00Z,1997-10-30T04:59:59Z,2024-01-17T02:00:08Z,97-22701,0,0,090000648047570f FDA-1995-N-0054-0002,FDA,FDA-1995-N-0054,FDA,Notice,NPR-Notice of Proposed Rule-Making,1997-08-22T04:00:00Z,1997,8,,,2008-05-16T22:28:56Z,,0,0,0900006480563a27 FDA-1997-N-0041-0001,FDA,FDA-1997-N-0041,Prescription Drug Products; Levothyroxine Sodium,Notice,N-Notice,1997-08-20T04:00:00Z,1997,8,1997-08-20T04:00:00Z,1997-10-15T03:59:59Z,2009-01-24T19:53:02Z,,0,0,09000064805cfc01 FDA-1997-N-0041-0002,FDA,FDA-1997-N-0041,Prescription Drug Products; Levothyroxine Sodium [re FDA-1997-N-0041-0001,Notice,N-Notice,1997-08-20T04:00:00Z,1997,8,1997-08-20T04:00:00Z,1997-10-15T03:59:59Z,2009-01-24T19:55:06Z,,0,0,09000064805cfc03 FDA-1992-F-0035-0003,FDA,FDA-1992-F-0035,Reference 3- Regarding Indirect Food Additives: Adhesives and Components of Coatings,Notice,Notice of Final Rule,1997-08-19T04:00:00Z,1997,8,1997-08-19T04:00:00Z,1997-09-12T03:59:59Z,2024-03-13T17:41:54Z,,0,0,0900006480528697 FDA-1992-F-0035-0002,FDA,FDA-1992-F-0035,Reference 1- Regarding Indirect Food Additives: Adhesives and Components of Coatings,Notice,Notice of Final Rule,1997-08-19T04:00:00Z,1997,8,1997-08-19T04:00:00Z,1997-09-12T03:59:59Z,2024-03-13T17:42:18Z,,0,0,0900006480528696 FDA-1992-F-0035-0001,FDA,FDA-1992-F-0035,Reference 2- Regarding Indirect Food Additives: Adhesives and Components of Coatings,Notice,Notice of Filing,1997-08-19T04:00:00Z,1997,8,1997-08-19T04:00:00Z,1997-09-12T03:59:59Z,2024-03-13T17:42:49Z,,0,0,090000648052868b FDA-1997-D-0048-0001,FDA,FDA-1997-D-0048,Draft Guidance for Industry; Consumer-Directed Broadcast Advertisements; Availability,Notice,Notice of Data Availability,1997-08-18T04:00:00Z,1997,8,1997-08-18T04:00:00Z,1997-10-15T03:59:59Z,2024-01-26T02:01:04Z,97-21291,0,0,09000064805cfc9f FDA-1997-N-0019-0021,FDA,FDA-1997-N-0019,"Duramed Pharm, Inc/Barr Labs., Inc",Notice,NPH-Notice of Opportunity of Hearing,1997-08-13T04:00:00Z,1997,8,1997-08-13T04:00:00Z,1997-09-09T03:59:59Z,2008-05-16T22:00:36Z,,0,0,09000064805ca03e FDA-1997-N-0019-0022,FDA,FDA-1997-N-0019,"Duramed Pharm, Inc/Barr Labs., Inc",Notice,NPH-Notice of Opportunity of Hearing,1997-08-13T04:00:00Z,1997,8,1997-08-13T04:00:00Z,1997-09-09T03:59:59Z,2008-05-16T22:00:37Z,,0,0,09000064805ca03f FDA-1997-N-0019-0008,FDA,FDA-1997-N-0019,"Duramed Pharm, Inc/Barr Labs., Inc",Notice,NPH-Notice of Opportunity of Hearing,1997-08-13T04:00:00Z,1997,8,1997-08-13T04:00:00Z,1997-09-09T03:59:59Z,2008-05-16T22:00:36Z,,0,0,09000064805ca031 FDA-1997-N-0019-0011,FDA,FDA-1997-N-0019,"Duramed Pharm, Inc/Barr Labs., Inc",Notice,NPH-Notice of Opportunity of Hearing,1997-08-13T04:00:00Z,1997,8,1997-08-13T04:00:00Z,1997-09-09T03:59:59Z,2008-05-16T22:00:36Z,,0,0,09000064805ca034 FDA-1997-N-0019-0016,FDA,FDA-1997-N-0019,"Duramed Pharm, Inc/Barr Labs., Inc",Notice,NPH-Notice of Opportunity of Hearing,1997-08-13T04:00:00Z,1997,8,1997-08-13T04:00:00Z,1997-09-09T03:59:59Z,2008-05-16T22:00:36Z,,0,0,09000064805ca039 FDA-1997-N-0019-0019,FDA,FDA-1997-N-0019,"Duramed Pharm, Inc/Barr Labs., Inc",Notice,NPH-Notice of Opportunity of Hearing,1997-08-13T04:00:00Z,1997,8,1997-08-13T04:00:00Z,1997-09-09T03:59:59Z,2008-05-16T22:00:36Z,,0,0,09000064805ca03c FDA-1997-N-0019-0001,FDA,FDA-1997-N-0019,"Duramed Pharm, Inc/Barr Labs., Inc",Notice,NPH-Notice of Opportunity of Hearing,1997-08-13T04:00:00Z,1997,8,1997-08-13T04:00:00Z,1997-09-09T03:59:59Z,2008-05-16T22:00:36Z,,0,0,09000064805ca02a FDA-1997-N-0019-0017,FDA,FDA-1997-N-0019,"Duramed Pharm, Inc/Barr Labs., Inc",Notice,NPH-Notice of Opportunity of Hearing,1997-08-13T04:00:00Z,1997,8,1997-08-13T04:00:00Z,1997-09-09T03:59:59Z,2008-05-16T22:00:37Z,,0,0,09000064805ca03a FDA-1997-N-0019-0020,FDA,FDA-1997-N-0019,"Duramed Pharm, Inc/Barr Labs., Inc",Notice,NPH-Notice of Opportunity of Hearing,1997-08-13T04:00:00Z,1997,8,1997-08-13T04:00:00Z,1997-09-09T03:59:59Z,2008-05-16T22:00:36Z,,0,0,09000064805ca03d FDA-1997-N-0019-0003,FDA,FDA-1997-N-0019,"Duramed Pharm, Inc/Barr Labs., Inc",Notice,NPH-Notice of Opportunity of Hearing,1997-08-13T04:00:00Z,1997,8,1997-08-13T04:00:00Z,1997-09-09T03:59:59Z,2008-05-16T22:00:37Z,,0,0,09000064805ca02c FDA-1997-N-0019-0012,FDA,FDA-1997-N-0019,"Duramed Pharm, Inc/Barr Labs., Inc",Notice,NPH-Notice of Opportunity of Hearing,1997-08-13T04:00:00Z,1997,8,1997-08-13T04:00:00Z,1997-09-09T03:59:59Z,2008-05-16T22:00:36Z,,0,0,09000064805ca035 FDA-1997-N-0019-0002,FDA,FDA-1997-N-0019,"Duramed Pharm, Inc/Barr Labs., Inc",Notice,NPH-Notice of Opportunity of Hearing,1997-08-13T04:00:00Z,1997,8,1997-08-13T04:00:00Z,1997-09-09T03:59:59Z,2008-05-16T22:00:37Z,,0,0,09000064805ca02b FDA-1997-N-0019-0006,FDA,FDA-1997-N-0019,"Duramed Pharm, Inc/Barr Labs., Inc",Notice,NPH-Notice of Opportunity of Hearing,1997-08-13T04:00:00Z,1997,8,1997-08-13T04:00:00Z,1997-09-09T03:59:59Z,2008-05-16T22:00:37Z,,0,0,09000064805ca02f FDA-1997-N-0019-0014,FDA,FDA-1997-N-0019,"Duramed Pharm, Inc/Barr Labs., Inc",Notice,NPH-Notice of Opportunity of Hearing,1997-08-13T04:00:00Z,1997,8,1997-08-13T04:00:00Z,1997-09-09T03:59:59Z,2008-05-16T22:00:36Z,,0,0,09000064805ca037 FDA-1997-N-0019-0009,FDA,FDA-1997-N-0019,"Duramed Pharm, Inc/Barr Labs., Inc",Notice,NPH-Notice of Opportunity of Hearing,1997-08-13T04:00:00Z,1997,8,1997-08-13T04:00:00Z,1997-09-09T03:59:59Z,2008-05-16T22:00:36Z,,0,0,09000064805ca032 FDA-1997-N-0019-0013,FDA,FDA-1997-N-0019,"Duramed Pharm, Inc/Barr Labs., Inc",Notice,NPH-Notice of Opportunity of Hearing,1997-08-13T04:00:00Z,1997,8,1997-08-13T04:00:00Z,1997-09-09T03:59:59Z,2008-05-16T22:00:36Z,,0,0,09000064805ca036 FDA-1997-N-0019-0015,FDA,FDA-1997-N-0019,"Duramed Pharm, Inc/Barr Labs., Inc",Notice,NPH-Notice of Opportunity of Hearing,1997-08-13T04:00:00Z,1997,8,1997-08-13T04:00:00Z,1997-09-09T03:59:59Z,2008-05-16T22:00:36Z,,0,0,09000064805ca038 FDA-1997-N-0019-0004,FDA,FDA-1997-N-0019,"Duramed Pharm, Inc/Barr Labs., Inc",Notice,NPH-Notice of Opportunity of Hearing,1997-08-13T04:00:00Z,1997,8,1997-08-13T04:00:00Z,1997-09-09T03:59:59Z,2008-05-16T22:00:37Z,,0,0,09000064805ca02d FDA-1997-N-0019-0007,FDA,FDA-1997-N-0019,"Duramed Pharm, Inc/Barr Labs., Inc",Notice,NPH-Notice of Opportunity of Hearing,1997-08-13T04:00:00Z,1997,8,1997-08-13T04:00:00Z,1997-09-09T03:59:59Z,2008-05-16T22:00:36Z,,0,0,09000064805ca030 FDA-1997-N-0019-0010,FDA,FDA-1997-N-0019,"Duramed Pharm, Inc/Barr Labs., Inc",Notice,NPH-Notice of Opportunity of Hearing,1997-08-13T04:00:00Z,1997,8,1997-08-13T04:00:00Z,1997-09-09T03:59:59Z,2008-05-16T22:00:37Z,,0,0,09000064805ca033 FDA-1997-N-0019-0018,FDA,FDA-1997-N-0019,"Duramed Pharm, Inc/Barr Labs., Inc",Notice,NPH-Notice of Opportunity of Hearing,1997-08-13T04:00:00Z,1997,8,1997-08-13T04:00:00Z,1997-09-09T03:59:59Z,2008-05-16T22:00:36Z,,0,0,09000064805ca03b FDA-1997-N-0019-0005,FDA,FDA-1997-N-0019,"Duramed Pharm, Inc/Barr Labs., Inc",Notice,NPH-Notice of Opportunity of Hearing,1997-08-13T04:00:00Z,1997,8,1997-08-13T04:00:00Z,1997-09-09T03:59:59Z,2008-05-16T22:00:36Z,,0,0,09000064805ca02e FDA-1997-N-0058-0001,FDA,FDA-1997-N-0058,FDA,Notice,NHC-Notice of Hearing Before Commissioner,1997-08-04T04:00:00Z,1997,8,1997-08-04T04:00:00Z,1997-11-13T04:59:59Z,2008-05-16T22:01:12Z,,0,0,09000064805d0252 FDA-1997-N-0060-0001,FDA,FDA-1997-N-0060,Animal Drug Availability Act; Medicated Feed Mill Licenses,Notice,NPR-Notice of Proposed Rule-Making,1997-07-31T00:00:00Z,1997,7,1997-07-30T04:00:00Z,1997-10-29T04:59:59Z,2025-05-15T16:22:19Z,97-19820,0,0,09000064805d02f0 FDA-1997-M-0062-0001,FDA,FDA-1997-M-0062,Perclose Inc.,Notice,NAL-Notice of Approval,1997-07-14T04:00:00Z,1997,7,1997-07-14T04:00:00Z,1997-08-08T03:59:59Z,2008-05-16T22:00:17Z,,0,0,09000064805d0322 FDA-1995-N-0054-0001,FDA,FDA-1995-N-0054,FDA,Notice,NPR-Notice of Proposed Rule-Making,1997-06-06T04:00:00Z,1997,6,1997-06-06T04:00:00Z,1997-08-19T03:59:59Z,2008-05-16T22:32:03Z,,0,0,090000648056205b FDA-1996-D-0024-0002,FDA,FDA-1996-D-0024,FDA,Notice,NAD-Notice of Availability of Data,1997-06-04T04:00:00Z,1997,6,,,2008-05-16T22:15:23Z,,0,0,09000064804fa9b4 FDA-1996-D-0044-0002,FDA,FDA-1996-D-0044,FDA,Notice,NAD-Notice of Availability of Data,1997-05-15T04:00:00Z,1997,5,,,2008-05-16T22:15:25Z,,0,0,09000064804fc65e FDA-1996-N-0028-0006,FDA,FDA-1996-N-0028,"Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements - Notice of Extension of Comment Period",Notice,NEC-Notice of Extension,1997-05-12T04:00:00Z,1997,5,1997-05-12T04:00:00Z,1997-06-07T03:59:59Z,2009-09-24T19:41:36Z,,0,0,09000064804fb83e FDA-1996-P-0031-0001,FDA,FDA-1996-P-0031,FDA,Notice,N-Notice,1997-04-07T04:00:00Z,1997,4,1997-04-07T04:00:00Z,1997-06-27T03:59:59Z,2008-05-16T22:20:07Z,,0,0,09000064804fc3de FDA-1995-P-0002-0001,FDA,FDA-1995-P-0002,FDA,Notice,N-Notice,1997-04-07T04:00:00Z,1997,4,1997-04-07T04:00:00Z,1997-06-27T03:59:59Z,2008-05-16T23:06:16Z,,0,0,0900006480558318 FDA-1997-D-0027-0001,FDA,FDA-1997-D-0027,FDA,Notice,NAD-Notice of Availability of Data,1997-04-07T04:00:00Z,1997,4,1997-04-07T04:00:00Z,1997-05-21T03:59:59Z,2008-05-16T21:59:18Z,,0,0,09000064805ca326 FDA-1996-P-0016-0001,FDA,FDA-1996-P-0016,FDA,Notice,NSA-Notice of Stay of Action,1997-04-02T05:00:00Z,1997,4,1997-04-02T05:00:00Z,1997-05-02T03:59:59Z,2008-05-16T22:19:41Z,,0,0,09000064804f9dea FDA-1992-S-0039-0001,FDA,FDA-1992-S-0039,Electronic Submissions; Establishment of Public Docket,Notice,N-Notice,1997-03-20T05:00:00Z,1997,3,,,2012-11-16T16:36:27Z,Vol 62 No 54,0,0,090000648052882e FDA-1996-E-0007-0001,FDA,FDA-1996-E-0007,Determination of Regulatory Review Period for Purposes of Patent Extension; CEREBYX®,Notice,General Notice,1997-03-20T05:00:00Z,1997,3,1997-03-20T05:00:00Z,1997-05-21T03:59:59Z,2024-09-16T16:54:52Z,,0,0,09000064804f99e6 FDA-1992-N-0016-0001,FDA,FDA-1992-N-0016,Electronic Records; Electronic Signatures,Notice,Notice of Final Rule,1997-03-20T05:00:00Z,1997,3,1997-03-20T05:00:00Z,1997-05-20T03:59:59Z,2024-03-30T01:00:44Z,,0,0,0900006480526524 FDA-1992-N-0016-0002,FDA,FDA-1992-N-0016,Electronic Records; Electronic Signatures,Notice,Notice of Final Rule,1997-03-20T05:00:00Z,1997,3,1997-03-20T05:00:00Z,1997-05-20T03:59:59Z,2024-03-29T13:24:17Z,,0,0,090000648052672d FDA-1995-N-0047-0003,FDA,FDA-1995-N-0047,Elimination of Establishment License Application for Specified Biotechnology and Specified Synthetic Biological Products; Correction,Notice,Correction,1997-03-18T05:00:00Z,1997,3,1997-03-13T05:00:00Z,,2025-06-03T15:44:12Z,97-6359,0,0,09000064805616f0 FDA-1994-P-0043-0011,FDA,FDA-1994-P-0043,FDA,Notice,NEC-Notice of Extension,1997-03-14T05:00:00Z,1997,3,1997-03-14T05:00:00Z,1997-04-25T03:59:59Z,2008-05-16T23:21:19Z,,0,0,09000064804ff4c1 FDA-1986-P-0023-0008,FDA,FDA-1986-P-0023,FDA,Notice,NPR-Notice of Proposed Rule-Making,1997-03-11T05:00:00Z,1997,3,1997-03-11T05:00:00Z,1997-05-28T03:59:59Z,2008-05-30T22:52:43Z,,0,0,090000648050de93 FDA-1996-D-0012-0001,FDA,FDA-1996-D-0012,FDA,Notice,N-Notice,1997-02-27T05:00:00Z,1997,2,,,2008-05-16T22:15:21Z,,0,0,09000064804f9b61 FDA-1996-N-0050-0002,FDA,FDA-1996-N-0050,FDA,Notice,NEC-Notice of Extension,1997-02-21T05:00:00Z,1997,2,1997-02-21T05:00:00Z,1997-04-29T03:59:59Z,2008-05-16T22:17:18Z,,0,0,09000064804fc9bf FDA-1997-N-0068-0001,FDA,FDA-1997-N-0068,Review of the Adverse Event Reporting System for Postmarketing Surveillance; Public Meeting,Notice,Meeting,1997-02-21T00:00:00Z,1997,2,1997-02-20T05:00:00Z,,2025-05-14T16:48:40Z,97-4161,0,0,09000064805d04f1 FDA-1996-D-0004-0003,FDA,FDA-1996-D-0004,FDA,Notice,NM-Notice of Meeting,1997-02-03T05:00:00Z,1997,2,,,2008-05-16T22:15:17Z,,0,0,09000064804f98f7 FDA-1994-P-0043-0003,FDA,FDA-1994-P-0043,FDA,Notice,NPR-Notice of Proposed Rule-Making,1997-01-29T05:00:00Z,1997,1,1997-01-29T05:00:00Z,1997-03-11T04:59:59Z,2008-05-16T23:21:15Z,,0,0,09000064804ff4a4 FDA-1997-N-0059-0001,FDA,FDA-1997-N-0059,Policy on Period of Marketing Exclusivity for Newly Approved Drug Products With Enantiomer Active Ingredients; Request for Comments,Notice,General Notice,1997-01-10T00:00:00Z,1997,1,1997-01-15T05:00:00Z,1997-03-18T04:59:59Z,2025-05-13T20:09:52Z,97-944,0,0,09000064805d02af FDA-1996-M-0053-0001,FDA,FDA-1996-M-0053,"Biora US, Inc.; Premarket Approval of EMDOGAIN®",Notice,Notice of Approval,1997-01-06T05:00:00Z,1997,1,1997-01-06T05:00:00Z,1996-12-24T04:59:59Z,2024-09-23T13:27:11Z,,0,0,09000064804fd2be