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

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

200 rows where agency_id = "FDA" and posted_year = 1997 sorted by posted_date descending

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posted_year 1

  • 1997 · 200 ✖

agency_id 1

  • FDA · 200 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1997-P-0033-0001 FDA Label Foods & Beverages Containing Greater Than 5mg Caffeine FDA-1997-P-0033 Acknowledgement Letter to University of Vermont Other ACK-Acknowledgement Letter 1997-12-02T05:00:00Z 1997 12     2024-11-01T01:00:57Z   0 0 09000064805ca3ae
FDA-1992-N-0007-0004 FDA Draft Policy Statement of Scientific&Educational Activity 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-1992-N-0007-0005 FDA Draft Policy Statement of Scientific&Educational Activity FDA-1992-N-0007 Industry Supported Scientific and Educational Activities: Guidance for Industry Other Guidance 1997-12-02T05:00:00Z 1997 12     2020-07-15T15:20:04Z   0 0 0900006480525bf0
FDA-1992-N-0007-0006 FDA Draft Policy Statement of Scientific&Educational Activity FDA-1992-N-0007 Industry-Supported Scientific and Educational Activites Supporting & Related Material Guidance 1997-12-02T05:00:00Z 1997 12     2020-05-15T14:00:31Z   0 0 0900006480525bf3
FDA-1996-N-0052-0001 FDA Class/Reclass; Restricted Devices; Analyte Specific Reagents 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-1977-N-0018-0080 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Acknowledgment Letter from FDA DDM re: Citizen Petition from Whitehall-Robins Healthcare (A Division of American Home Products Corporation) (Volume 1 of 4) Other Acknowledgement Letter/Receipt 1997-11-28T05:00:00Z 1997 11     2019-02-05T13:16:24Z   0 0 09000064805d9b9d
FDA-1978-N-0022-0019 FDA Over-the-Counter (OTC) External Analgesic Drug Products- OPEN FDA-1978-N-0022 Antifungal Drug Products for Over-the-Counter Human Use; External Analgesic Drug Products for Over-the-Counter Human Use; Skin Protectant Drug Products for Over-the-Counter Human Use; and Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Reopening of Administrative Records Proposed Rule Notice of Proposed Rulemaking (NPRM) 1997-11-21T05:00:00Z 1997 11 1997-11-21T05:00:00Z 1998-02-18T04:59:59Z 2020-02-04T12:52:44Z 97-30410 0 0 090000648055ebe7
FDA-1978-N-0027-0004 FDA Skin Protectant Drugs for O. T. C. Human Use FDA-1978-N-0027 Antifungal Drug Products for Over-The-Counter Human Use; External Analgesic Drug Products for Over-The-Counter Human Use; Skin Protectant Drug Products for Over-The-Counter Human Use; and Topical Antimicrobial Drug Products for Over-The-Counter Human Use; Reopening of Administrative Records Proposed Rule Notice of Proposed Rulemaking (NPRM) 1997-11-21T05:00:00Z 1997 11 1997-11-19T05:00:00Z 1998-02-18T04:59:59Z 2019-08-01T15:43:51Z 97-30410 0 0 0900006480560ce9
FDA-1997-M-0021-0003 FDA Approval for implantable defilibrillators and programmers 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 Approval for implantable defilibrillators and programmers 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 Approval for implantable defilibrillators and programmers 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-1995-N-0029-0005 FDA Requirements for Nutrient Content Claims; Health Claims FDA-1995-N-0029 Food Labeling; Nutrient Content Claims: Definition for “High Potency” and Definitions of “Antioxidant” for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods; Correction Rule NCR-Notice of Correction 1997-10-30T05:00:00Z 1997 10     2008-06-17T16:55:54Z   0 0 090000648055a53f
FDA-1980-N-0074-0061 FDA Anticaries Drug Products for OTC Human Use; FDA-1980-N-0074 HFD-560 to Buc & Beardsley Other LET-Letter 1997-10-24T04:00:00Z 1997 10     2008-05-30T22:52:54Z   0 0 09000064805bb48c
FDA-1997-P-0035-0002 FDA Clarify specific data for approval of abbret new drug application-CLOSED FDA-1997-P-0035 Acknowledgement Letter from FDA DMB to Kleinfeld, Kaplan & Becker Other Acknowledgement Letter/Receipt 1997-10-22T04:00:00Z 1997 10     2025-01-28T18:51:06Z   0 0 09000064805ca427
FDA-1997-P-0035-0001 FDA Clarify specific data for approval of abbret new drug application-CLOSED FDA-1997-P-0035 Acknowledgement Letter from FDA DMB to Kleinfeld, Kaplan & Becker Other Acknowledgement Letter/Receipt 1997-10-22T04:00:00Z 1997 10     2025-01-28T18:48:14Z   0 0 09000064805ca41f
FDA-1997-P-0054-0002 FDA Amend strength in fludeoxyglucose injection-CLOSED FDA-1997-P-0054 Acknowledgement Letter to the Center for Positron Emission Tomography, State University of New York at Buffalo, Department of Nuclear Medicine Other ACK-Acknowledgement Letter 1997-10-21T04:00:00Z 1997 10     2013-07-28T01:52:43Z   0 0 09000064805cfd15
FDA-1993-N-0043-0005 FDA Adverse Experience Reporting Requirements Drug/Biologicals 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 Adverse Experience Reporting Requirements Drug/Biologicals 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 Adverse Experience Reporting Requirements Drug/Biologicals 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-1980-N-0074-0060 FDA Anticaries Drug Products for OTC Human Use; FDA-1980-N-0074 HFA-305 to Amway Corporation Other ACK-Acknowledgement Letter 1997-10-08T04:00:00Z 1997 10     2008-05-30T22:52:54Z   0 0 09000064805bb48b
FDA-1995-N-0029-0004 FDA Requirements for Nutrient Content Claims; Health Claims FDA-1995-N-0029 Food Labeling; Nutrient Content Claims: Definition for “High Potency” and Definitions of “Antioxidant” for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods Rule NFR-Notice of Final Rule 1997-10-03T04:00:00Z 1997 10     2008-06-17T16:50:37Z   0 0 090000648055a53a
FDA-1995-N-0029-0003 FDA Requirements for Nutrient Content Claims; Health Claims FDA-1995-N-0029 Food Labeling; Requirements for Nutrient Content Claims, Health Claims, and Statements of Nutritional Support for Dietary Supplements Rule NFR-Notice of Final Rule 1997-10-01T04:00:00Z 1997 10     2008-06-17T16:59:19Z   0 0 090000648055a536
FDA-1980-N-0036-0011 FDA Antifungal Drug Products for O. T. C. Human Use FDA-1980-N-0036 Nonprecription Drugs Advisory Committee-April 15, 1997 Transcript Other TR-Transcript 1997-09-22T04:00:00Z 1997 9     2012-10-04T19:34:01Z   0 0 09000064805b9489
FDA-1995-N-0054-0003 FDA Ephedrine Alkaloids: Reports of Adverse Events; Availability 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-1996-N-0027-0006 FDA National Environmental Policy Act Proposed Revision of Policies and Procedures FDA-1996-N-0027 National Environmental Policy Act Proposed Revision of Policies and Procedures Correction Rule Correction 1997-09-16T04:00:00Z 1997 9     2014-01-19T17:23:25Z   0 0 09000064804fb631
FDA-1991-F-0039-0001 FDA Safe use of Silicone Acrylate Resins for coating 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-1980-N-0074-0059 FDA Anticaries Drug Products for OTC Human Use; FDA-1980-N-0074 Acknowledgement Letter from FDA HFA 305 to Tom's of Maine Other Acknowledgement Letter/Receipt 1997-09-12T04:00:00Z 1997 9     2022-05-25T20:47:17Z   0 0 09000064805bb488
FDA-1980-N-0074-0058 FDA Anticaries Drug Products for OTC Human Use; FDA-1980-N-0074 Letter from FDA to Buc & Beardsly Other Letter(s) 1997-09-10T04:00:00Z 1997 9     2022-05-25T16:50:43Z   0 0 09000064805bb486
FDA-1980-N-0074-0057 FDA Anticaries Drug Products for OTC Human Use; FDA-1980-N-0074 Citizen Petition Approval Response Letter from FDA/CDER to Tom's of Maine Other Approval 1997-09-02T04:00:00Z 1997 9     2022-05-25T15:55:24Z   0 0 09000064805bb484
FDA-1997-P-0003-0001 FDA ANDA for mefenamic acid tablets, 250mg.-CLOSED FDA-1997-P-0003 FDA/CDER Response to Pitney, Hardin, Kipp & Szuch - Petition Approval Other Approval 1997-09-02T04:00:00Z 1997 9     2025-02-05T21:10:40Z   0 0 09000064805c9547
FDA-1980-N-0074-0056 FDA Anticaries Drug Products for OTC Human Use; FDA-1980-N-0074 Memorandum of Telephone Conversation Between FDA and Tom's of Maine Other Memorandum 1997-08-29T04:00:00Z 1997 8     2022-05-16T21:06:03Z   0 0 09000064805bb483
FDA-1989-N-0019-0002 FDA Prescription Labeling for Geriatric Use 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 Prescription Labeling for Geriatric Use 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 Ephedrine Alkaloids: Reports of Adverse Events; Availability 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 Prescription Drug Products; Levothyroxine Sodium 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 Prescription Drug Products; Levothyroxine Sodium 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 3-pentadecenyl phenol mixture 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 3-pentadecenyl phenol mixture 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 3-pentadecenyl phenol mixture 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 Consumer-Directed Broadcast Advertisements 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 Conjugated Estrogens Tablets 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 Conjugated Estrogens Tablets 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 Conjugated Estrogens Tablets 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 Conjugated Estrogens Tablets 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 Conjugated Estrogens Tablets 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 Conjugated Estrogens Tablets 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 Conjugated Estrogens Tablets 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 Conjugated Estrogens Tablets 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 Conjugated Estrogens Tablets 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 Conjugated Estrogens Tablets 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 Conjugated Estrogens Tablets 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 Conjugated Estrogens Tablets 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 Conjugated Estrogens Tablets 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 Conjugated Estrogens Tablets 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 Conjugated Estrogens Tablets 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 Conjugated Estrogens Tablets 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 Conjugated Estrogens Tablets 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 Conjugated Estrogens Tablets 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 Conjugated Estrogens Tablets 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 Conjugated Estrogens Tablets 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 Conjugated Estrogens Tablets 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 Conjugated Estrogens Tablets 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-1980-N-0074-0055 FDA Anticaries Drug Products for OTC Human Use; FDA-1980-N-0074 HFD-560 to Buc & Beardsley Other LET-Letter 1997-08-08T04:00:00Z 1997 8     2008-05-30T22:53:16Z   0 0 09000064805bb482
FDA-1997-P-0353-0003 FDA Withdraw Approval Intramucular for Injectable Iron Dextran FDA-1997-P-0353 Luitpold Pharmaceuticals, Inc., (Arent Fox) - Amendment (Citizen Petition) Other AMD-Amendment 1997-08-08T04:00:00Z 1997 8     2024-11-12T04:54:59Z   1 0 0900006480b336f6
FDA-1996-N-0027-0005 FDA National Environmental Policy Act Proposed Revision of Policies and Procedures FDA-1996-N-0027 National Environmental Policy Act Proposed Revision of Policies and Procedures Pages 101 Thru 157 Rule Final Rule 1997-08-04T04:00:00Z 1997 8 1997-08-04T04:00:00Z 1997-07-30T03:59:59Z 2014-01-19T17:24:33Z   0 0 09000064804fb630
FDA-1996-N-0027-0004 FDA National Environmental Policy Act Proposed Revision of Policies and Procedures FDA-1996-N-0027 National Environmental Policy Act Proposed Revision of Policies and Procedures Pages 1 Thru 100 Rule Final Rule 1997-08-04T04:00:00Z 1997 8 1997-08-04T04:00:00Z 1997-07-30T03:59:59Z 2014-01-19T17:24:19Z   0 0 09000064804fb62f
FDA-1997-N-0058-0001 FDA Pregnancy Labeling; Content & Format Requirements 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-P-0026-0001 FDA Require Quantitative Labeling of Caffeine Content FDA-1997-P-0026 Acknowledgement Letter to Center for Science in the Public Interest Other ACK-Acknowledgement Letter 1997-08-01T04:00:00Z 1997 8     2008-06-24T22:54:25Z   0 0 09000064805ca170
FDA-1997-P-0013-0001 FDA Premarin Conjugated Estrogens must identify active ingredien FDA-1997-P-0013 Acknowledgment Letter from FDA DMB to Cooper & Carvin, PLLC Other Acknowledgement Letter/Receipt 1997-07-31T04:00:00Z 1997 7     2024-10-02T01:00:48Z   0 0 09000064805c9b37
FDA-1997-N-0060-0001 FDA Feed mill license in accord with Animal Drug Avalblty Act 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 PMA of Prostar Percutaneous Vascular Surgical (PVS) System 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-1997-A-0012-0001 FDA Advisory opinion on labeling of contact lens FDA-1997-A-0012 HFA-305 to Burditt & Razius, Chartered Other ACK-Acknowledgement Letter 1997-07-11T04:00:00Z 1997 7     2008-05-16T21:58:42Z   0 0 09000064805c9b0d
FDA-1978-N-0018-0460 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Acknowledgment Letter from FDA DDM to Schering-Plough Healthcare Products Other Acknowledgement Letter/Receipt 1997-07-08T04:00:00Z 1997 7     2019-07-23T16:04:36Z   0 0 090000648055a8bb
FDA-1997-P-0022-0002 FDA PSA/standardization of certain grass pollen extracts-CLOSED FDA-1997-P-0022 Acknowledgement Letter from FDA DMB to Hogan & Hartson L.L.P. Other Acknowledgement Letter/Receipt 1997-07-02T04:00:00Z 1997 7     2025-02-12T19:23:01Z   0 0 09000064805ca12d
FDA-1997-P-0022-0003 FDA PSA/standardization of certain grass pollen extracts-CLOSED FDA-1997-P-0022 Acknowledgement Letter from FDA DMB to Hogan & Hartson L.L.P. Other Acknowledgement Letter/Receipt 1997-07-02T04:00:00Z 1997 7     2025-02-12T19:28:19Z   0 0 09000064805ca12e
FDA-1993-P-0037-0002 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Acknowledgement Letter from FDA DMB to Wiley, Rein & Fielding Other Acknowledgement Letter/Receipt 1997-07-02T04:00:00Z 1997 7     2025-01-28T14:48:40Z   0 0 09000064804fbefb
FDA-1997-P-0022-0001 FDA PSA/standardization of certain grass pollen extracts-CLOSED FDA-1997-P-0022 Acknowledgement Letter from FDA DMB to Hogan & Hartson L.L.P. Other Acknowledgement Letter/Receipt 1997-07-01T04:00:00Z 1997 7     2025-02-12T19:19:47Z   0 0 09000064805ca111
FDA-1997-P-0044-0001 FDA Approved Drug Product List with Therapeutic Eqivalence Evaluation be amended by designating second reference listed drug for albuterol sulfate extended release tablets, eg 4 mg-CLOSED FDA-1997-P-0044 Acknowledgment Letter from FDA DDM to McDermont, Will and Emery Other Acknowledgement Letter/Receipt 1997-06-26T04:00:00Z 1997 6     2017-08-17T17:11:22Z   0 0 09000064805cfc71
FDA-1996-P-0246-0005 FDA Establishes RACCs for Various Types of Food Products Candies FDA-1996-P-0246 Interim Response Letter from FDA CFSAN to Chocolate Manufacturers Association (CMA) and National Confectioners Association (NCA) Other Letter(s) 1997-06-23T04:00:00Z 1997 6 2014-02-20T05:00:00Z   2014-02-20T13:41:21Z   0 0 0900006480503974
FDA-1997-P-0032-0001 FDA Approve ANDA 74-662 for Ranitidine Hydrochloride FDA-1997-P-0032 Acknowledgement Letter from FDA DMB to Cohen, Pontani, Lieberman & Pavane Other Acknowledgement Letter/Receipt 1997-06-18T04:00:00Z 1997 6     2024-09-11T01:00:41Z   0 0 09000064805ca395
FDA-1997-P-0002-0001 FDA Issue a final approval for its ANDA 74-488 effective 7/10/97-CLOSED FDA-1997-P-0002 Acknowledgement Letter from FDA DMB to Olsson, Frank & Weeda, P.C. Other Acknowledgement Letter/Receipt 1997-06-12T04:00:00Z 1997 6     2025-01-29T02:01:01Z   0 0 09000064805c953a
FDA-1995-S-0039-0030 FDA 75-Day Premarket Notifications for New Dietary Ingredients FDA-1995-S-0039 Report from FDA/CFSAN Other RPT-Report 1997-06-08T04:00:00Z 1997 6 2008-09-28T04:00:00Z   2016-09-30T14:19:47Z   0 0 090000648055c2f3
FDA-1995-N-0054-13910 FDA Ephedrine Alkaloids: Reports of Adverse Events; Availability FDA-1995-N-0054 Background Information to NPR1 Supporting & Related Material BKG-Background Material 1997-06-06T04:00:00Z 1997 6     2008-05-16T22:32:00Z   0 0 090000648056b92d
FDA-1995-N-0054-13901 FDA Ephedrine Alkaloids: Reports of Adverse Events; Availability FDA-1995-N-0054 Background Information to NPR1 Supporting & Related Material BKG-Background Material 1997-06-06T04:00:00Z 1997 6     2008-05-16T22:27:51Z   0 0 090000648056b90e
FDA-1995-N-0054-13926 FDA Ephedrine Alkaloids: Reports of Adverse Events; Availability FDA-1995-N-0054 Background Information to NPR1 Supporting & Related Material BKG-Background Material 1997-06-06T04:00:00Z 1997 6     2008-05-16T22:32:00Z   0 0 090000648056b94f
FDA-1995-N-0054-13916 FDA Ephedrine Alkaloids: Reports of Adverse Events; Availability FDA-1995-N-0054 Background Information to NPR1 Supporting & Related Material BKG-Background Material 1997-06-06T04:00:00Z 1997 6     2008-05-16T22:31:17Z   0 0 090000648056b93a
FDA-1995-N-0054-13917 FDA Ephedrine Alkaloids: Reports of Adverse Events; Availability FDA-1995-N-0054 Background Information to NPR1 Supporting & Related Material BKG-Background Material 1997-06-06T04:00:00Z 1997 6     2008-05-16T22:27:51Z   0 0 090000648056b93c
FDA-1995-N-0054-13906 FDA Ephedrine Alkaloids: Reports of Adverse Events; Availability FDA-1995-N-0054 Background Information to NPR1 Supporting & Related Material BKG-Background Material 1997-06-06T04:00:00Z 1997 6     2008-05-16T22:30:32Z   0 0 090000648056b922
FDA-1995-N-0054-13902 FDA Ephedrine Alkaloids: Reports of Adverse Events; Availability FDA-1995-N-0054 Background Information to NPR1 Supporting & Related Material BKG-Background Material 1997-06-06T04:00:00Z 1997 6     2008-05-16T22:33:27Z   0 0 090000648056b913
FDA-1995-N-0054-13918 FDA Ephedrine Alkaloids: Reports of Adverse Events; Availability FDA-1995-N-0054 Background Information to NPR1 Supporting & Related Material BKG-Background Material 1997-06-06T04:00:00Z 1997 6     2008-05-16T22:28:40Z   0 0 090000648056b93f
FDA-1995-N-0054-0001 FDA Ephedrine Alkaloids: Reports of Adverse Events; Availability 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-1995-N-0054-13904 FDA Ephedrine Alkaloids: Reports of Adverse Events; Availability FDA-1995-N-0054 Background Information to NPR1 Supporting & Related Material BKG-Background Material 1997-06-06T04:00:00Z 1997 6     2008-05-16T22:33:27Z   0 0 090000648056b918
FDA-1995-N-0054-13933 FDA Ephedrine Alkaloids: Reports of Adverse Events; Availability FDA-1995-N-0054 Background Information to NPR1 Supporting & Related Material BKG-Background Material 1997-06-06T04:00:00Z 1997 6     2008-05-16T22:28:40Z   0 0 090000648056b97c
FDA-1995-N-0054-13908 FDA Ephedrine Alkaloids: Reports of Adverse Events; Availability FDA-1995-N-0054 Background Information to NPR1 Supporting & Related Material BKG-Background Material 1997-06-06T04:00:00Z 1997 6     2008-05-16T22:33:27Z   0 0 090000648056b927
FDA-1995-N-0054-13905 FDA Ephedrine Alkaloids: Reports of Adverse Events; Availability FDA-1995-N-0054 Background Information to NPR1 Supporting & Related Material BKG-Background Material 1997-06-06T04:00:00Z 1997 6     2008-05-16T22:30:32Z   0 0 090000648056b91a
FDA-1995-N-0054-13923 FDA Ephedrine Alkaloids: Reports of Adverse Events; Availability FDA-1995-N-0054 Background Information to NPR1 Supporting & Related Material BKG-Background Material 1997-06-06T04:00:00Z 1997 6     2008-05-16T22:29:25Z   0 0 090000648056b94a
FDA-1995-N-0054-13927 FDA Ephedrine Alkaloids: Reports of Adverse Events; Availability FDA-1995-N-0054 Background Information to NPR1 Supporting & Related Material BKG-Background Material 1997-06-06T04:00:00Z 1997 6     2008-05-16T22:31:17Z   0 0 090000648056b951
FDA-1995-N-0054-13937 FDA Ephedrine Alkaloids: Reports of Adverse Events; Availability FDA-1995-N-0054 Background Information to NPR1 Supporting & Related Material BKG-Background Material 1997-06-06T04:00:00Z 1997 6     2008-05-16T22:29:25Z   0 0 090000648056b986
FDA-1995-N-0054-13941 FDA Ephedrine Alkaloids: Reports of Adverse Events; Availability FDA-1995-N-0054 Background Information to NPR1 Supporting & Related Material BKG-Background Material 1997-06-06T04:00:00Z 1997 6     2008-05-16T22:27:53Z   0 0 090000648056b98e
FDA-1995-N-0054-13940 FDA Ephedrine Alkaloids: Reports of Adverse Events; Availability FDA-1995-N-0054 Background Information to NPR1 Supporting & Related Material BKG-Background Material 1997-06-06T04:00:00Z 1997 6     2008-05-16T22:32:45Z   0 0 090000648056b98c

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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);