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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

176 rows where agency_id = "FDA" and posted_year = 1994 sorted by posted_date descending

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posted_year 1

  • 1994 · 176 ✖

agency_id 1

  • FDA · 176 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1986-V-0022-0007 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) 1994-12-30T05:00:00Z 1994 12     2023-01-18T18:31:29Z   0 0 090000648050dd41
FDA-1988-N-0028-0002 FDA Pediatric dosing information for OTC; request for informatio FDA-1988-N-0028 FDA Notice NAD-Notice of Availability of Data 1994-12-27T05:00:00Z 1994 12 1994-12-27T05:00:00Z 1995-03-15T04:59:59Z 2008-05-30T22:53:14Z   0 0 0900006480476632
FDA-1994-P-0049-0003 FDA Regulate Cigarettes Containing Nicotine as Drugs or Devices-CLOSED FDA-1994-P-0049 HFA-305 to Action on Smoking and Health (ASH) Other ACK-Acknowledgement Letter 1994-12-23T05:00:00Z 1994 12     2008-05-16T23:21:33Z   0 0 09000064804ffa14
FDA-1991-N-0041-0004 FDA Medical Devices; Substantial Equivalence; 510K Summaries FDA-1991-N-0041 Medical Devices; Substantial Equivalence; 510(k) Summaries and 510(k) Statements; Class III Summaries; Confidentiality of Information Notice Notice of Final Rule 1994-12-20T05:00:00Z 1994 12     2023-09-01T14:49:14Z 94-30422 0 0 090000648052a20f
FDA-1994-F-0010-0001 FDA Amend regulations to permit the manufacture of Mannitol FDA-1994-F-0010 Roquette America, Inc.; Filing of Food Additive Petition Notice Notice of Filing 1994-12-15T05:00:00Z 1994 12 1994-12-15T05:00:00Z 1995-01-13T04:59:59Z 2024-05-28T14:03:33Z 94-30585 0 0 09000064804fc65b
FDA-1994-F-0010-0005 FDA Amend regulations to permit the manufacture of Mannitol FDA-1994-F-0010 Environmental Assessment from Roquette America, Inc. Supporting & Related Material Environmental Assessment 1994-12-15T05:00:00Z 1994 12     2024-05-28T14:18:41Z   0 0 09000064804fc664
FDA-1981-N-0012-0010 FDA OTC Weight Control Drug Products for Human Use FDA-1981-N-0012 HFA-305 to Caprice-Greystoke, Ltd Other ACK-Acknowledgement Letter 1994-12-14T05:00:00Z 1994 12     2008-05-30T22:53:23Z   0 0 09000064805ae8d5
FDA-1981-N-0043-0004 FDA Pediculicide Drug Products for OTC Human Use FDA-1981-N-0043 Marketing of Over-the-Counter Pediculicide Drug Products; Background Documents; Availability Notice Notice of Data Availability 1994-12-13T05:00:00Z 1994 12     2021-03-15T13:05:51Z 94-29987 0 0 09000064805af2eb
FDA-1993-N-0043-0002 FDA Adverse Experience Reporting Requirements Drug/Biologicals FDA-1993-N-0043 Adverse Experience Reporting Requirements for Human Drug and Licensed Biological Products; Correction Notice Correction 1994-12-05T05:00:00Z 1994 12     2024-04-29T14:48:41Z   0 0 09000064804fc3bb
FDA-1982-P-0018-0388 FDA Reclassify Electroconvulsive Therapy (ECT) Section 513(E)-CLOSED FDA-1982-P-0018 Acknowledgment Letter from FDA Dockets Management Branch to Edward R. Hutchinson Other Acknowledgement Letter/Receipt 1994-12-01T05:00:00Z 1994 12     2025-01-07T12:57:06Z   0 0 090000648050e72b
FDA-1994-N-0035-0003 FDA Methods of the Allergenic Products Testing Laboratory FDA-1994-N-0035 Methods of the Allergenics Products Testing Laboratory Supporting & Related Material BKG-Background Material 1994-11-30T05:00:00Z 1994 11     2008-05-16T23:15:32Z   0 0 09000064804fd698
FDA-1994-N-0035-0002 FDA Methods of the Allergenic Products Testing Laboratory FDA-1994-N-0035 Methods of the Allergenics Products Testing Laboratory Supporting & Related Material BKG-Background Material 1994-11-30T05:00:00Z 1994 11     2008-05-16T23:15:32Z   0 0 09000064804fd68e
FDA-1994-N-0035-0001 FDA Methods of the Allergenic Products Testing Laboratory FDA-1994-N-0035 Methods of the Allergenic Products Testing Laboratory; Availability Notice Notice of Availability 1994-11-30T05:00:00Z 1994 11     2024-10-04T20:23:52Z   0 0 09000064804fd68b
FDA-1975-N-0012-0001 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Draft FRN - Topical Antimicrobial Drug Products for Over-the Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products; Extension of Comment and New Data Periods Proposed Rule Notice of Extension 1994-11-28T05:00:00Z 1994 11 1994-11-28T05:00:00Z 2019-04-04T03:59:59Z 2019-04-03T01:03:54Z FR Doc. 94- 28063 0 0 09000064805c1908
FDA-1994-P-0045-0001 FDA Finished Medical Gases - Exemption from Certain Regulations-CLOSED FDA-1994-P-0045 Acknowledgment Letter from FDA DMB to Medical Gases Committee Other Acknowledgement Letter/Receipt 1994-11-28T05:00:00Z 1994 11     2024-07-01T14:53:49Z   0 0 09000064804ff6c5
FDA-1994-P-0042-0001 FDA Revoke Guide on Buspirone Bioequivalence Testing-CLOSED FDA-1994-P-0042 Acknowledgment Letter from FDA DMB to Fox, Bennett & Turner Other Acknowledgement Letter/Receipt 1994-11-22T05:00:00Z 1994 11     2024-06-18T15:39:19Z   0 0 09000064804ff3dd
FDA-1992-N-0007-0003 FDA Draft Policy Statement of Scientific&Educational Activity FDA-1992-N-0007 FDA Notice N-Notice 1994-11-17T05:00:00Z 1994 11 1994-11-17T05:00:00Z 1995-02-17T04:59:59Z 2008-05-16T23:31:45Z   0 0 0900006480525b33
FDA-1994-N-0037-0002 FDA General Biologics and Licensing Regulations FDA-1994-N-0037 FDA Notice NEC-Notice of Extension 1994-11-16T05:00:00Z 1994 11 1994-11-16T05:00:00Z 1995-02-14T04:59:59Z 2008-05-16T23:15:39Z   0 0 09000064804fd7ff
FDA-1993-N-0043-0001 FDA Adverse Experience Reporting Requirements Drug/Biologicals FDA-1993-N-0043 Adverse Experience Reporting Requirements for Human Drug and Licensed Biological Products Notice NPR-Notice of Proposed Rule-Making 1994-11-15T05:00:00Z 1994 11 1994-11-15T05:00:00Z 1995-01-26T04:59:59Z 2024-04-29T14:42:48Z   0 0 09000064804fc3b4
FDA-1994-M-0011-0001 FDA PMA Sonic Accelerated Fracture Healing System FDA-1994-M-0011 Exogen Inc., Premarket Approval of Sonic Accelerated Fracture Healing System (SAFHS) Notice Notice of Approval 1994-11-14T05:00:00Z 1994 11 1994-11-14T05:00:00Z 1994-12-10T04:59:59Z 2024-06-07T14:52:20Z 94-27222 0 0 09000064804fc6e1
FDA-1994-N-0030-0001 FDA Proposal to Debar; John D. Copanos; Opportunity for Hearing FDA-1994-N-0030 FDA Notice Notice of Opportunity of Hearing 1994-11-14T05:00:00Z 1994 11 1994-11-14T05:00:00Z 1994-12-10T04:59:59Z 2024-12-07T20:22:46Z   0 0 09000064804fd3d1
FDA-1994-E-0047-0001 FDA Risperdal; Patent Term Extension Application No. 4,804,663 FDA-1994-E-0047 Determination of Regulatory Review Period for Purposes of Patent Extension; Risperdal® Notice General Notice 1994-10-27T04:00:00Z 1994 10 1994-10-27T04:00:00Z 1994-11-01T04:59:59Z 2024-05-23T16:08:19Z   0 0 09000064804ff746
FDA-1993-N-0043-0009 FDA Adverse Experience Reporting Requirements Drug/Biologicals FDA-1993-N-0043 Background Material Supporting & Related Material BKG-Background Material 1994-10-26T04:00:00Z 1994 10     2008-05-16T23:24:08Z   0 0 09000064804fc45c
FDA-1993-N-0043-0011 FDA Adverse Experience Reporting Requirements Drug/Biologicals FDA-1993-N-0043 Background Material Supporting & Related Material BKG-Background Material 1994-10-26T04:00:00Z 1994 10     2008-05-16T23:24:08Z   0 0 09000064804fc45e
FDA-1993-N-0043-0008 FDA Adverse Experience Reporting Requirements Drug/Biologicals FDA-1993-N-0043 Background Material Supporting & Related Material BKG-Background Material 1994-10-26T04:00:00Z 1994 10     2008-05-16T23:24:10Z   0 0 09000064804fc45b
FDA-1993-N-0043-0012 FDA Adverse Experience Reporting Requirements Drug/Biologicals FDA-1993-N-0043 Background Material Supporting & Related Material BKG-Background Material 1994-10-26T04:00:00Z 1994 10     2008-05-16T23:24:10Z   0 0 09000064804fc45f
FDA-1993-N-0043-0010 FDA Adverse Experience Reporting Requirements Drug/Biologicals FDA-1993-N-0043 Background Material Supporting & Related Material BKG-Background Material 1994-10-26T04:00:00Z 1994 10     2008-05-16T23:24:09Z   0 0 09000064804fc45d
FDA-1981-N-0012-0011 FDA OTC Weight Control Drug Products for Human Use FDA-1981-N-0012 HFA-305 to Caprice-Greystoke, Ltd Other ACK-Acknowledgement Letter 1994-10-24T04:00:00Z 1994 10     2008-05-30T22:53:23Z   0 0 09000064805ae8d6
FDA-1994-P-0013-0009 FDA Reference Amount of Wild Rice-CLOSED FDA-1994-P-0013 Acknowledgment Letter from FDA DMB to Minnesota Cultivated Wild Rice Council Other Acknowledgement Letter/Receipt 1994-10-18T04:00:00Z 1994 10     2024-06-27T03:41:49Z   0 0 09000064804fc7e5
FDA-1978-N-0018-0135 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Letter from FDA CDER to Arlington Dermatology Clinic South Other Letter(s) 1994-10-17T04:00:00Z 1994 10     2019-07-22T16:53:28Z   0 0 090000648055a1d7
FDA-1975-N-0012-0049 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Request for Extension from Amway Corporation Other Request for Extension 1994-10-13T04:00:00Z 1994 10     2017-11-20T17:41:08Z   0 0 09000064805c1947
FDA-1994-M-0011-0003 FDA PMA Sonic Accelerated Fracture Healing System FDA-1994-M-0011 Approval Letter from FDA CDRH to Exogen, Inc. Other Approval 1994-10-05T04:00:00Z 1994 10     2024-06-07T15:10:49Z   0 0 09000064804fc71e
FDA-1994-P-0034-0001 FDA Certify Mercury/Silver (amalgam)-Classify & Issue Warning FDA-1994-P-0034 HFA-305 to Reeves & Graddy Other ACK-Acknowledgement Letter 1994-09-27T04:00:00Z 1994 9     2008-05-16T23:19:11Z   0 0 09000064804fd60a
FDA-1993-D-0019-0001 FDA Stability Testing of Biotechnological/Biological Products FDA-1993-D-0019 FDA Notice NAD-Notice of Availability of Data 1994-09-27T04:00:00Z 1994 9     2008-05-16T23:22:51Z   0 0 09000064804fa914
FDA-1978-N-0018-0133 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Letter from FDA CDER to Person & Covey, Inc. Other Letter(s) 1994-09-15T04:00:00Z 1994 9     2019-07-22T15:37:29Z   0 0 090000648055a1c0
FDA-1985-V-0043-0001 FDA XISCAN MODEL 1000 DIAGNOSTIC X-RAY SYSTEM/CONFIDENTIAL FDA-1985-V-0043 FDA/CDRH Other LET-Letter 1994-09-12T04:00:00Z 1994 9     2008-05-30T22:53:19Z   0 0 09000064805b5d16
FDA-1978-N-0018-0132 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Memorandum of Telephone Conversation between Arent, Fox, Kintner, Plotkin & Kahn and FDA/CDER, August 22, 1994 Other Memorandum 1994-09-06T04:00:00Z 1994 9     2019-08-02T14:52:14Z   0 0 090000648055a19c
FDA-1976-N-0027-0004 FDA OTC Nasal Decongestants FDA-1976-N-0027 Notice of Final Rule re Partial Stay of Regulation; Enforcement Policy Notice Notice of Final Rule 1994-08-25T04:00:00Z 1994 8     2015-10-29T20:26:59Z   0 0 090000648051b679
FDA-1994-M-0032-0001 FDA PMA of Model 1700, 1705 AICD, 2850 PRESCRIPTOR & Model 2860 FDA-1994-M-0032 Cardiac Pacemakers, Inc., Premarket Approval of VENTAK@ PRx@ Model 1700 and Model 1705 AICD Tm System, Model 2850 PRESCRIPTOR TM Programmer and Model 2860 Program Disk Notice Notice of Approval 1994-08-16T04:00:00Z 1994 8 1994-08-16T04:00:00Z 1994-09-15T03:59:59Z 2024-06-03T15:59:13Z   0 0 09000064804fd418
FDA-1994-G-0039-0004 FDA Safe Use In Food Triglyceride Containing Caprylic & Capric - Closed FDA-1994-G-0039 Background Material re Captrin for Use as a Fat in Foods for Human Consumption Supporting & Related Material Background Material 1994-08-11T04:00:00Z 1994 8     2016-04-15T14:49:10Z   0 0 09000064804fd8fe
FDA-1994-G-0039-0002 FDA Safe Use In Food Triglyceride Containing Caprylic & Capric - Closed FDA-1994-G-0039 Background Material re Captrin for Use as a Fat in Foods for Human Consumption Supporting & Related Material Background Material 1994-08-11T04:00:00Z 1994 8     2016-04-15T14:50:22Z   0 0 09000064804fd8eb
FDA-1994-G-0039-0001 FDA Safe Use In Food Triglyceride Containing Caprylic & Capric - Closed FDA-1994-G-0039 Notice of Filing re Safe Use In Food Triglyceride Containing Caprylic & Capric Notice Notice of Filing 1994-08-11T04:00:00Z 1994 8 1994-08-11T04:00:00Z 1994-10-05T03:59:59Z 2016-04-08T19:06:48Z   0 0 09000064804fd8c3
FDA-1994-G-0039-0003 FDA Safe Use In Food Triglyceride Containing Caprylic & Capric - Closed FDA-1994-G-0039 Background Material re Captrin for Use as a Fat in Foods for Human Consumption Supporting & Related Material Background Material 1994-08-11T04:00:00Z 1994 8     2016-04-15T14:30:39Z   0 0 09000064804fd8fb
FDA-1978-N-0018-0130 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Internal Memorandum from Director Monograph Review Staff (HFD-810) to Dockets Management Branch (HFA-305) August 3, 1994 re: Comment from Canadian Dermatology Association Supporting & Related Material Comment(s) 1994-08-08T04:00:00Z 1994 8     2019-08-02T16:35:11Z   0 0 090000648055a16d
FDA-1994-P-0005-0001 FDA Issue regulations provide consistency use of term "sugar" FDA-1994-P-0005 Acknowledgment Letter from FDA DMB to The Sugar Association Other Acknowledgement Letter/Receipt 1994-08-03T04:00:00Z 1994 8     2024-07-01T13:54:19Z   0 0 09000064804fc55a
FDA-1994-P-0012-0009 FDA Amend monograph to include Valerian as OTC sleep-aid product-CLOSED FDA-1994-P-0012 HFA-305 to Bass & Ullman, P. C. Other ACK-Acknowledgement Letter 1994-07-28T04:00:00Z 1994 7     2008-05-16T23:18:51Z   0 0 09000064804fc786
FDA-1994-P-0012-0010 FDA Amend monograph to include Valerian as OTC sleep-aid product-CLOSED FDA-1994-P-0012 HFA-305 to Bass & Ullman, P. C. Other ACK-Acknowledgement Letter 1994-07-28T04:00:00Z 1994 7     2008-05-16T23:18:51Z   0 0 09000064804fc787
FDA-1978-N-0018-0129 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Correction to Memorandum of Meeting between FDA/CDER, et al., and Givauden-Roure Corporation, et al., May 11, 1994 from FDA/CDER Other Correction(s) 1994-07-28T04:00:00Z 1994 7     2019-07-23T15:57:14Z   0 0 090000648055a12c
FDA-1978-N-0018-0459 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Acknowledgment Letter from FDA/DDM to Arent Fox Kintner Plotkin & Kahn on behalf of Estee Lauder, Inc. Other Acknowledgement Letter/Receipt 1994-07-28T04:00:00Z 1994 7     2019-07-23T15:01:45Z   0 0 090000648055a8b8
FDA-1978-N-0018-0128 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Letter from FDA/CDER to Ivy Laboratories Other Letter(s) 1994-07-27T04:00:00Z 1994 7     2019-07-22T18:55:33Z   0 0 090000648055a126
FDA-1992-N-0056-0004 FDA Prescription Drug Marketing Act of 1987, Drug Amds of 1992 FDA-1992-N-0056 Notice of Extension re Prescription Drug Marketing Act of 1987, Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Reopening of Comment Period Notice Notice of Extension 1994-07-25T04:00:00Z 1994 7 1994-07-25T04:00:00Z 1994-08-16T03:59:59Z 2017-08-04T13:26:56Z   0 0 090000648052bf07
FDA-1994-M-0008-0001 FDA PMA Model PC-28LB Posterior Chamber Intraocular Lens FDA-1994-M-0008 Allergan Medical Optics; Premarket Approval of the Model PC-28LB Ultraviolet-Absorbing Posterior Chamber Intraocular Lens Notice Notice of Approval 1994-07-21T04:00:00Z 1994 7 1994-07-21T04:00:00Z 1994-08-18T03:59:59Z 2024-05-28T11:53:44Z 94-17374 0 0 09000064804fc60a
FDA-1978-N-0018-0127 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Letter from FDA/CDER to Temple University Medical Practices Other Letter(s) 1994-07-19T04:00:00Z 1994 7     2019-07-22T18:26:46Z   0 0 090000648055a11b
FDA-1994-P-0028-0001 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Acknowledgment Letter from FDA DDM to Mckenna & Cuneo Other Acknowledgement Letter/Receipt 1994-07-12T04:00:00Z 1994 7     2017-10-07T21:38:33Z   0 0 09000064804fd339
FDA-1986-D-0038-0009 FDA Guideline Labeling for Estrogen Drug Products FDA-1986-D-0038 FDA Notice NAD-Notice of Availability of Data 1994-07-08T04:00:00Z 1994 7     2008-05-30T22:52:43Z   0 0 090000648050e78f
FDA-1986-D-0038-0008 FDA Guideline Labeling for Estrogen Drug Products FDA-1986-D-0038 FDA Notice NAD-Notice of Availability of Data 1994-07-08T04:00:00Z 1994 7     2008-05-30T22:52:51Z   0 0 090000648050e78e
FDA-1975-N-0016-0021 FDA OTC Topical Antimicrobial Drug Products - OPEN FDA-1975-N-0016 Letter from FDA CDER to Ciba-Geigy Corporation Other Letter(s) 1994-07-08T04:00:00Z 1994 7     2017-09-25T19:36:18Z   0 0 09000064805c2277
FDA-1986-D-0038-0010 FDA Guideline Labeling for Estrogen Drug Products FDA-1986-D-0038 FDA Notice NAD-Notice of Availability of Data 1994-07-08T04:00:00Z 1994 7     2008-05-30T22:52:58Z   0 0 090000648050e790
FDA-1978-N-0018-0125 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Memorandum of Meeting between FDA/CDER, et al., and Givauden-Roure Corporation, et al., May 11, 1994 Other Memorandum 1994-07-07T04:00:00Z 1994 7     2019-07-22T17:58:20Z   0 0 090000648055a116
FDA-1994-P-0040-0001 FDA Establish Federal Standards of Identity for Tortillas, etc. FDA-1994-P-0040 Acknowledgment Letter from FDA DMB to Tortilla Industry Association Other ACK-Acknowledgement Letter 1994-06-30T04:00:00Z 1994 6     2024-07-30T01:01:05Z   0 0 09000064804fd9ce
FDA-1978-N-0018-0124 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Letter from FDA CDER to King & Spaulding Other Letter(s) 1994-06-30T04:00:00Z 1994 6     2019-07-29T18:43:55Z   0 0 090000648055a10e
FDA-1978-N-0018-0123 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Memorandum of Meeting between FDA/CDER, Dr. Madhu Pathak, et al., and Givaudan-Roure Corporation, et al., May 12, 1994 Other Memorandum 1994-06-30T04:00:00Z 1994 6     2019-09-04T17:19:22Z   0 0 090000648055a10b
FDA-1994-M-0056-0001 FDA Premarket Approval of Parastep I System FDA-1994-M-0056 Sigmedics, Inc.; Premarket Approval of Parastep I System Notice Notice of Approval 1994-06-17T04:00:00Z 1994 6 1994-06-17T04:00:00Z 1994-07-15T03:59:59Z 2024-05-28T12:29:52Z 94-14315 0 0 090000648050388e
FDA-1994-F-0057-0001 FDA Safe use of 1-bromo-3-chloro-5,5-dimethylhydantoin FDA-1994-F-0057 Great Lakes Chemical Corp.; Filing of Food Additive Petition Notice Notice of Filing 1994-06-17T04:00:00Z 1994 6 1994-06-17T04:00:00Z 1994-07-15T03:59:59Z 2024-05-24T15:57:09Z 94-14371 0 0 09000064805038b0
FDA-1993-E-0006-0001 FDA Reality Female Condom; Patent Term Exten App No. 4,735,621 FDA-1993-E-0006 FDA Notice N-Notice 1994-06-17T04:00:00Z 1994 6 1994-06-17T04:00:00Z 1994-08-16T03:59:59Z 2008-05-16T23:23:12Z   0 0 09000064804f9b7e
FDA-1975-N-0012-0044 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Topical Antimicrobial Drug Products for Over-the Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products Proposed Rule Notice of Proposed Rulemaking (NPRM) 1994-06-16T04:00:00Z 1994 6 1994-06-16T04:00:00Z 1994-12-15T04:59:59Z 2017-10-16T12:01:00Z 94-14503 0 0 09000064805c190b
FDA-1994-N-0037-0001 FDA General Biologics and Licensing Regulations FDA-1994-N-0037 FDA Notice NI-Notice of Intent 1994-06-15T04:00:00Z 1994 6 1994-06-15T04:00:00Z 1994-08-18T03:59:59Z 2008-05-16T23:15:38Z   0 0 09000064804fd7ca
FDA-1978-N-0018-0122 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Sunscreen Drug Products for Over-The-Counter Human Use; Proposed Amendment to the Tentative Final Monograph; Reopening of Comment Period Notice Notice of Extension 1994-06-14T04:00:00Z 1994 6 1994-06-14T04:00:00Z 1994-08-23T03:59:59Z 2019-07-19T19:49:02Z 94-13933 0 0 090000648055a108
FDA-1994-P-0012-0008 FDA Amend monograph to include Valerian as OTC sleep-aid product-CLOSED FDA-1994-P-0012 HFA-305 to Akin, Gump, Strauss, Hauer & Feld, L. L. P. Other ACK-Acknowledgement Letter 1994-06-09T04:00:00Z 1994 6     2008-05-16T23:18:51Z   0 0 09000064804fc785
FDA-1992-N-0017-0005 FDA Bottled Water; Chemical Quality Standards for Copper & Lead FDA-1992-N-0017 FDA Notice NFR-Notice of Final Rule 1994-06-01T04:00:00Z 1994 6     2008-05-16T23:32:01Z   0 0 0900006480526aaf
FDA-1992-N-0017-0002 FDA Bottled Water; Chemical Quality Standards for Copper & Lead FDA-1992-N-0017 FDA Notice NFR-Notice of Final Rule 1994-06-01T04:00:00Z 1994 6     2008-05-16T23:32:01Z   0 0 0900006480526aa6
FDA-1992-N-0017-0006 FDA Bottled Water; Chemical Quality Standards for Copper & Lead FDA-1992-N-0017 FDA Notice NFR-Notice of Final Rule 1994-06-01T04:00:00Z 1994 6     2008-05-16T23:32:00Z   0 0 0900006480526ab4
FDA-1994-M-0009-0001 FDA Premarket Approval of OrthoLogic 1000 FDA-1994-M-0009 OrthoLogic Corp.; Premarket Approval of Orthologic 1000 Notice Notice of Approval 1994-06-01T04:00:00Z 1994 6     2024-05-28T13:34:36Z 94-12374 0 0 09000064804fc625
FDA-1992-N-0017-0004 FDA Bottled Water; Chemical Quality Standards for Copper & Lead FDA-1992-N-0017 FDA Notice NFR-Notice of Final Rule 1994-06-01T04:00:00Z 1994 6     2008-05-16T23:32:01Z   0 0 0900006480526aac
FDA-1992-N-0017-0003 FDA Bottled Water; Chemical Quality Standards for Copper & Lead FDA-1992-N-0017 FDA Notice NFR-Notice of Final Rule 1994-06-01T04:00:00Z 1994 6     2008-05-16T23:32:01Z   0 0 0900006480526aa9
FDA-1992-E-0012-0002 FDA Supprelin; Patent Extension Application No. 4,244,946 FDA-1992-E-0012 Determination of Regulatory Review Period for Purposes of Patent Extension; Supprelin; Correction Notice Correction 1994-05-26T04:00:00Z 1994 5     2023-09-25T11:46:30Z 94-9047 0 0 0900006480526109
FDA-1980-N-0057-0012 FDA Ophthalmic Drug Products FDA-1980-N-0057 Petition Denial Letter from FDA (HFC-1) to Alcon Laboratories, Inc. Other Denial 1994-05-26T04:00:00Z 1994 5     2022-03-23T18:44:49Z   0 0 09000064805ba5c0
FDA-1994-P-0002-0002 FDA Modify Ingred Label for In-Store Prepared Take-Out Food FDA-1994-P-0002 Acknowledgment Letter from FDA DMB to Food Marketing Institute Other Acknowledgement Letter/Receipt 1994-05-20T04:00:00Z 1994 5     2024-06-24T17:30:16Z   0 0 09000064804fc4b4
FDA-1993-N-0057-0026 FDA Lead in Food & Color Additives & GRAS Ingredients FDA-1993-N-0057 FDA Notice NEC-Notice of Extension 1994-05-19T04:00:00Z 1994 5 1994-05-19T04:00:00Z 1994-08-04T03:59:59Z 2008-05-16T23:24:17Z   0 0 09000064804fc6c1
FDA-1993-N-0013-0007 FDA Improvements in the Drug Master File System FDA-1993-N-0013 FDA Notice NEC-Notice of Extension 1994-05-19T04:00:00Z 1994 5 1994-05-19T04:00:00Z 1994-06-04T03:59:59Z 2008-05-16T23:23:57Z   0 0 09000064804fa495
FDA-1993-P-0034-0001 FDA Postpone Regulations & Rules re: Calgene's FAP Aminoglycoside 3'-Phosphotransferase II (APH(3')II) in Tomatoes, Cotton and Oilseed Rape-CLOSED FDA-1993-P-0034 Petition Denial Response Letter from FDA ORA to The Foundation on Economic Trends Other Denial of Petition 1994-05-19T04:00:00Z 1994 5     2017-06-19T15:08:07Z   0 0 09000064804fb940
FDA-1978-N-0018-0120 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Letter from FDA/CDER to King & Spalding Other Letter(s) 1994-05-12T04:00:00Z 1994 5     2019-07-22T18:47:28Z   0 0 090000648055a020
FDA-1993-N-0057-0027 FDA Lead in Food & Color Additives & GRAS Ingredients FDA-1993-N-0057 Background Material Supporting & Related Material BKG-Background Material 1994-05-04T04:00:00Z 1994 5     2008-05-16T23:24:16Z   0 0 09000064804fc71d
FDA-1982-P-0018-0387 FDA Reclassify Electroconvulsive Therapy (ECT) Section 513(E)-CLOSED FDA-1982-P-0018 Acknowledgement Letter from FDA Dockets Management Branch to Edward R. Hutchinson Other Acknowledgement Letter/Receipt 1994-05-03T04:00:00Z 1994 5     2025-01-06T15:53:08Z   0 0 090000648050e72a
FDA-1994-M-0019-0001 FDA PMA of the Medtronic Transvene Lead System FDA-1994-M-0019 Medtronic, Inc.; Premarket Approval of the Medtronic® Transvene® Lead System Notice NAL-Notice of Approval 1994-04-28T04:00:00Z 1994 4 1994-04-28T04:00:00Z 1994-05-20T03:59:59Z 2009-01-29T18:57:08Z   0 0 09000064804fcb03
FDA-1992-N-0056-0003 FDA Prescription Drug Marketing Act of 1987, Drug Amds of 1992 FDA-1992-N-0056 Envelope re Comment from Pharmaceutical Manufacturers Association Supporting & Related Material Transmittals 1994-04-26T04:00:00Z 1994 4     2016-03-15T14:29:57Z   0 0 090000648052be8e
FDA-1992-N-0056-0001 FDA Prescription Drug Marketing Act of 1987, Drug Amds of 1992 FDA-1992-N-0056 Notice of Proposed Rulemaking re Prescription Drug Marketing Act of 1987, Drug Amendments of 1992 Proposed Rule NPR-Notice of Proposed Rule-Making 1994-04-26T04:00:00Z 1994 4 1994-04-26T04:00:00Z 1994-05-31T03:59:59Z 2017-08-05T19:09:08Z   0 0 090000648052be86
FDA-1994-M-0046-0001 FDA PMA, Rotate Platform Configuration NJ LCS Total Knee System FDA-1994-M-0046 DePuy, Inc.; Premarket Approval of the Rotating Platform Configuration of the New Jersey LCSB Total Knee System Notice Notice of Approval 1994-04-26T04:00:00Z 1994 4 1994-04-26T04:00:00Z 1994-05-19T03:59:59Z 2024-06-04T13:21:46Z   0 0 09000064804ff6ee
FDA-1992-N-0056-0002 FDA Prescription Drug Marketing Act of 1987, Drug Amds of 1992 FDA-1992-N-0056 Notice of Proposed Rulemaking re Prescription Drug Marketing Act of 1987, Drug Amds of 1992 Proposed Rule Notice of Proposed Rulemaking (NPRM) 1994-04-26T04:00:00Z 1994 4 1994-04-26T04:00:00Z 1994-05-31T03:59:59Z 2016-03-15T14:00:22Z   0 0 090000648052be8c
FDA-1981-N-0043-0008 FDA Pediculicide Drug Products for OTC Human Use FDA-1981-N-0043 Acknowledgment Letter from FDA DMS to Nonprescription Drug Manufacturers Association Other Acknowledgement Letter/Receipt 1994-04-25T04:00:00Z 1994 4     2021-03-15T13:37:42Z   0 0 09000064805af2fa
FDA-1994-P-0015-0002 FDA Refrain from Approving Any ANDA's for Terfenadine-CLOSED FDA-1994-P-0015 Acknowledgment Letter from FDA DMB to Kleinfeld Kaplan & Becker Other Acknowledgement Letter/Receipt 1994-04-14T04:00:00Z 1994 4     2024-07-29T15:37:51Z   0 0 09000064804fc971
FDA-1994-P-0015-0001 FDA Refrain from Approving Any ANDA's for Terfenadine-CLOSED FDA-1994-P-0015 Acknowledgment Letter from FDA DMB to Kleinfeld Kaplan & Becker Other Acknowledgement Letter/Receipt 1994-04-14T04:00:00Z 1994 4     2024-07-29T15:24:07Z   0 0 09000064804fc904
FDA-1994-P-0048-0001 FDA Withdraw Interim Guideline on Albuterol Inhalation Aerosols-CLOSED FDA-1994-P-0048 Acknowledgment Letter from FDA DMB to Glaxo Inc. Other Acknowledgement Letter/Receipt 1994-04-13T04:00:00Z 1994 4     2024-06-18T13:27:13Z   0 0 09000064804ff83a
FDA-1992-E-0012-0003 FDA Supprelin; Patent Extension Application No. 4,244,946 FDA-1992-E-0012 Acknowledgement Letter from FDA Dockets Management Branch to Fitch, Even, Tabin & Flannery Other Acknowledgement Letter/Receipt 1994-04-08T04:00:00Z 1994 4     2023-09-25T11:57:36Z   0 0 090000648052610d
FDA-1978-N-0021-0004 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Tab B: Supporting & related materials Supporting & Related Material Background Material 1994-04-07T04:00:00Z 1994 4     2016-09-16T16:55:56Z   0 0 090000648055d115
FDA-1978-N-0021-0006 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Tab A: Products complaints and published materials Supporting & Related Material Background Material 1994-04-07T04:00:00Z 1994 4     2016-09-16T16:55:21Z   0 0 090000648055d11d
FDA-1978-N-0021-0005 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Notice of Proposed Rulemaking -Laxative Drug Products For Over-The-Counter Human Use; Proposed Amendment To The Tentative Final Monograph Proposed Rule Notice of Proposed Rulemaking (NPRM) 1994-04-07T04:00:00Z 1994 4 1994-04-07T04:00:00Z 1994-06-01T03:59:59Z 2016-08-03T19:58:19Z   0 0 090000648055d119
FDA-1978-N-0018-0117 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Answer Letter from FDA/CDER to Dr. Beverly Summers Other Letter(s) 1994-04-06T04:00:00Z 1994 4     2019-07-22T12:23:19Z   0 0 0900006480559fad
FDA-1978-N-0018-0119 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Answer Letter from FDA/CDER to Nicholas J. Lowe Other Letter(s) 1994-04-06T04:00:00Z 1994 4     2019-07-22T12:32:57Z   0 0 0900006480559fd3
FDA-1978-N-0018-0118 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Answer Letter from FDA/CDER to James L. Boren Other Letter(s) 1994-04-06T04:00:00Z 1994 4     2019-07-22T12:28:04Z   0 0 0900006480559fb4

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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,
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    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,
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);
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);