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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

62 rows where document_type = "Other" and posted_year = 1997 sorted by posted_date descending

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posted_year 1

  • 1997 · 62 ✖

document_type 1

  • Other · 62 ✖

agency_id 1

  • FDA 62
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0007-0005 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-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-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-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-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-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-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-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-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-1997-P-0036-0001 FDA Listed drug capsules change in dosage form and strengths-CLOSED FDA-1997-P-0036 Acknowledgement Letter from FDA DMB to Direction Generals et Medicate Other Acknowledgement Letter/Receipt 1997-06-06T04:00:00Z 1997 6     2024-11-01T21:04:22Z   0 0 09000064805ca430
FDA-1997-P-0023-0001 FDA Exclusivity for ANDA 74-023, Ranitidine Hydrochloride FDA-1997-P-0023 Acknowledgement Letter from FDA DMB to Williams & Connolly Other Acknowledgement Letter/Receipt 1997-06-02T04:00:00Z 1997 6     2024-09-10T15:26:13Z   0 0 09000064805ca135
FDA-1993-N-0032-0003 FDA Debar Robert Shulman; Notice of Opportunity for Hearing FDA-1993-N-0032 Letter from FDA to Robert Shulman Other Letter(s) 1997-05-29T04:00:00Z 1997 5     2023-08-08T18:13:48Z   0 0 09000064804fb82d
FDA-1995-P-0051-0002 FDA Ban the Use of Lindane as a Treatment for Lice and Scabies-CLOSED FDA-1995-P-0051 Petition Denial Letter from FDA CDER to Public Citizen Other Denial of Petition 1997-05-21T04:00:00Z 1997 5     2025-09-15T21:39:54Z   0 0 0900006480561e58
FDA-1995-P-0051-0001 FDA Ban the Use of Lindane as a Treatment for Lice and Scabies-CLOSED FDA-1995-P-0051 Petition Denial Letter from FDA CDER to Cancer Prevention Coalition Other Denial of Petition 1997-05-21T04:00:00Z 1997 5     2025-09-15T21:35:58Z   0 0 0900006480561e16
FDA-1997-P-0034-0002 FDA Prohibit Approval of Generic Versions of Toradol-CLOSED FDA-1997-P-0034 HFA-305 to Hoffman-La Roche Inc. Other ACK-Acknowledgement Letter 1997-05-02T04:00:00Z 1997 5     2008-05-16T22:05:53Z   0 0 09000064805ca416
FDA-1997-P-0034-0001 FDA Prohibit Approval of Generic Versions of Toradol-CLOSED FDA-1997-P-0034 HFA-305 to Hoffman-La Roche Inc. Other ACK-Acknowledgement Letter 1997-05-02T04:00:00Z 1997 5     2008-05-16T22:05:53Z   0 0 09000064805ca40e
FDA-1994-P-0001-0002 FDA Classify of All Cigarette Products as Drugs-CLOSED FDA-1994-P-0001 HFA-305 to Williams & Connolly Other ACK-Acknowledgement Letter 1997-04-18T04:00:00Z 1997 4     2008-05-16T23:17:22Z   0 0 09000064804fc376
FDA-1997-P-0003-0002 FDA ANDA for mefenamic acid tablets, 250mg.-CLOSED FDA-1997-P-0003 Acknowledgement Letter to Pitney, Hardin, Kipp & Szuch Other ACK-Acknowledgement Letter 1997-04-15T04:00:00Z 1997 4     2013-09-16T21:07:24Z   0 0 09000064805c954c
FDA-1997-P-0007-0001 FDA Artificially Sweetened Fruit Jelly and Artificially Sweetened Fruit Preserves and Jams; Revocation of Standards of Identity FDA-1997-P-0007 HFA-305 to International Jelly & Preserve Assn. Other ACK-Acknowledgement Letter 1997-04-08T04:00:00Z 1997 4     2008-05-16T22:05:14Z   0 0 09000064805c99b1
FDA-1980-P-0012-0012 FDA Showlasers model LP1-CLOSED FDA-1980-P-0012 Approval for Variance from FDA/CDRH to Showlasers, Inc. Other Approval for Variance (VRA) 1997-04-08T04:00:00Z 1997 4     2021-02-24T17:04:46Z   0 0 09000064805b926b
FDA-1994-P-0012-0003 FDA Amend monograph to include Valerian as OTC sleep-aid product-CLOSED FDA-1994-P-0012 Director, Division of OTC Drug Products, Center for Drug Evaluation & Research (HFD-560) Other LET-Letter 1997-03-25T05:00:00Z 1997 3     2008-05-16T23:18:51Z   0 0 09000064804fc780
FDA-1994-P-0012-0004 FDA Amend monograph to include Valerian as OTC sleep-aid product-CLOSED FDA-1994-P-0012 Director, Division of OTC Drug Products, Center for Drug Evaluation & Research (HFD-560) Other LET-Letter 1997-03-25T05:00:00Z 1997 3     2008-05-16T23:18:51Z   0 0 09000064804fc781
FDA-1994-P-0012-0002 FDA Amend monograph to include Valerian as OTC sleep-aid product-CLOSED FDA-1994-P-0012 Director, Division of OTC Drug Products, Center for Drug Evaluation & Research (HFD-560) Other LET-Letter 1997-03-25T05:00:00Z 1997 3     2008-05-16T23:18:51Z   0 0 09000064804fc77f
FDA-1994-P-0012-0001 FDA Amend monograph to include Valerian as OTC sleep-aid product-CLOSED FDA-1994-P-0012 Director, Division of OTC Drug Products, Center for Drug Evaluation & Research (HFD-560) Other LET-Letter 1997-03-25T05:00:00Z 1997 3     2008-05-16T23:18:51Z   0 0 09000064804fc736
FDA-1980-N-0074-0054 FDA Anticaries Drug Products for OTC Human Use; FDA-1980-N-0074 Memorandum from FDA CDER to Richard Finn, President Chesebrough-Pond's USA Co. Other Memorandum 1997-03-16T05:00:00Z 1997 3     2022-05-11T19:57:20Z   0 0 09000064805bb481
FDA-1978-N-0018-0428 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Letter from FDA CDER to Covington and Burling Other Letter(s) 1997-03-12T05:00:00Z 1997 3     2019-07-23T15:01:47Z   0 0 090000648055a5ed
FDA-1980-N-0074-0052 FDA Anticaries Drug Products for OTC Human Use; FDA-1980-N-0074 Letter from FDA HFD-560 to Nonprescription Drug Manufacturers Association Other Letter(s) 1997-03-12T05:00:00Z 1997 3     2022-05-11T19:42:06Z   0 0 09000064805bb47f
FDA-1978-N-0018-0430 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Letter from FDA CDER to McKenna, Conner & Cuneo Other Letter(s) 1997-03-12T05:00:00Z 1997 3     2019-07-23T15:11:48Z   0 0 090000648055a5ef
FDA-1978-N-0018-0427 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Letter from FDA CDER to Morgan, Lewis & Bockius on behalf of B. A. S. F. AG Other Letter(s) 1997-03-12T05:00:00Z 1997 3     2019-07-23T14:58:33Z   0 0 090000648055a5ec
FDA-1980-N-0074-0053 FDA Anticaries Drug Products for OTC Human Use; FDA-1980-N-0074 Letter from FDA HFD-560 to Patton Boggs, L. L. P. Other Letter(s) 1997-03-12T05:00:00Z 1997 3     2022-05-11T19:46:26Z   0 0 09000064805bb480
FDA-1978-N-0018-0429 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Letter from FDA CDER to Rona Pearl, Associate of E. Merck, Darmstadt West Germany Other Letter(s) 1997-03-12T05:00:00Z 1997 3     2019-07-23T15:08:42Z   0 0 090000648055a5ee
FDA-1997-P-0001-0001 FDA Refrain from granting AVITA an "A" Rating, (Orange Book) FDA-1997-P-0001 Acknowledgement Letter from FDA DMB to Ortho Pharmaceutical Corporation Other Acknowledgement Letter/Receipt 1997-03-10T05:00:00Z 1997 3     2024-09-05T16:11:37Z   0 0 09000064805c952a
FDA-1991-V-0023-0003 FDA Las Vegas laser rental light shows. FDA-1991-V-0023 Variance Approval Letter from FDA CDRH to Las Vegas Laser Rental Other Approval for Variance (VRA) 1997-03-05T05:00:00Z 1997 3     2023-10-13T11:55:53Z   0 0 090000648052867e
FDA-1986-V-0022-0008 FDA Ion laser technology series ILT 5000 Demo unit FDA-1986-V-0022 Variance Approval Letter from FDA CDRH to California Technical Associates Other Approval for Variance (VRA) 1997-03-05T05:00:00Z 1997 3     2023-01-18T18:34:45Z   0 0 090000648050dd43
FDA-1997-P-0016-0001 FDA Recognized the Term "Soymilk" as the Established Common of Usual Name. FDA-1997-P-0016 Acknowledgement Letter to Soyfoods Association of America Other Acknowledgement Letter/Receipt 1997-03-03T05:00:00Z 1997 3     2015-02-07T23:23:10Z   0 0 09000064805c9b6c
FDA-1978-N-0018-0426 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Letter from FDA CDER to Ariana Italiana Image & Fragrances, Ltd. Other Letter(s) 1997-02-27T05:00:00Z 1997 2     2019-07-23T14:45:33Z   0 0 090000648055a5ea
FDA-1997-E-0063-0002 FDA Patent Term Extension Application for Reteplase; U.S. Patent No. 5,223,256 FDA-1997-E-0063 Letter from FDA to U.S. Patent and Trademark Office Other Letter(s) 1997-02-10T05:00:00Z 1997 2     2024-09-23T19:24:26Z   0 0 09000064805d033b
FDA-1997-P-0055-0001 FDA Definitions & Standards of Identity for Bakery Products-CLOSED FDA-1997-P-0055 Acknowledgement Letter to the American Bakers Association (ABA) Other ACK-Acknowledgement Letter 1997-02-04T05:00:00Z 1997 2     2013-07-27T22:09:11Z   0 0 09000064805cfd23
FDA-1995-S-0039-0029 FDA 75-Day Premarket Notifications for New Dietary Ingredients FDA-1995-S-0039 Report from FDA/CFSAN Other RPT-Report 1997-01-29T05:00:00Z 1997 1 2008-09-28T04:00:00Z   2016-09-30T14:19:47Z   0 0 090000648055c2f1
FDA-1997-E-0063-0001 FDA Patent Term Extension Application for Reteplase; U.S. Patent No. 5,223,256 FDA-1997-E-0063 Letter from USPTO to FDA/OHA Other Letter(s) 1997-01-15T05:00:00Z 1997 1     2024-09-23T19:22:00Z   0 0 09000064805d0336
FDA-1995-S-0039-0028 FDA 75-Day Premarket Notifications for New Dietary Ingredients FDA-1995-S-0039 Report from FDA/CFSAN Other RPT-Report 1997-01-15T05:00:00Z 1997 1 2008-09-28T04:00:00Z   2016-09-30T14:19:47Z   0 0 090000648055c2ea
FDA-1997-P-0053-0001 FDA Provide Warning Labels for Prozac to Consumers-CLOSED FDA-1997-P-0053 Acknowledgement Letter from FDA DMB to Rosellen Meysenburg Other Acknowledgement Letter/Receipt 1997-01-10T05:00:00Z 1997 1     2024-08-23T12:53:37Z   0 0 09000064805cfd06

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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);
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