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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

47 rows where docket_id = "FDA-1978-N-1446" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1978-N-1446-0036 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Reference A Rorer Research Monograph Emetrol re: Supplement from William H. Rorer, Inc. Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T16:06:25Z   0 0 0900006482054511
FDA-1978-N-1446-0037 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Reference C Federal Register Notices Vol. 40 No. 56 pg 12937 March 21, 1975 and Vol. 44 No. 136 pg 41071 July 13, 1979 re: Supplement from William H. Rorer, Inc. Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T16:10:01Z   0 0 0900006482054513
FDA-1978-N-1446-0038 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Reference D Physicians' Desk Reference re: Supplement from William H. Rorer, Inc. Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T16:11:04Z   0 0 0900006482054514
FDA-1978-N-1446-0039 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Reference E Product Information on Emetrol re: Supplement from William H. Rorer, Inc. Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T16:12:24Z   0 0 0900006482054515
FDA-1978-N-1446-0018 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Tab 2 Statement of the Regulatory Analysis Assessment of the Tentative Order for a Monograph for OTC Antiemetic Drug Products re: Antiemetic TFM Administrative Record (78N-0036) 44FR41064 Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T14:46:28Z   0 0 0900006482057857
FDA-1978-N-1446-0041 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Memorandum from OTC Drug Evaluation (CDER) to DDM Other Memorandum 2016-06-30T04:00:00Z 2016 6 2016-06-30T04:00:00Z   2016-06-30T16:26:12Z   0 0 090000648059b3eb
FDA-1978-N-1446-0028 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Letter from William H. Rorer, Inc. to OTC Drug Evaluation (CDER) Other Letter(s) 2016-06-30T04:00:00Z 2016 6 2016-06-30T04:00:00Z   2016-06-30T15:20:29Z   0 0 090000648059b3e7
FDA-1978-N-1446-0025 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Objection from Environmental Defense Fund and Public Citizen Health Research Group Other Objection(s) 2016-06-30T04:00:00Z 2016 6 2016-06-30T04:00:00Z   2016-06-30T15:08:14Z   0 0 090000648059b3e3
FDA-1978-N-1446-0024 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Objection and Request for Hearing from Norwich-Eaton Pharmaceuticals Other Objection(s) 2016-06-30T04:00:00Z 2016 6 2016-06-30T04:00:00Z   2016-06-30T15:01:51Z   0 0 090000648059b3e2
FDA-1978-N-1446-0042 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Letter from OTC Drug Evaluation (CDER) to William H. Rorer, Inc. Other Letter(s) 2016-06-30T04:00:00Z 2016 6 2016-06-30T04:00:00Z   2016-06-30T16:28:57Z   0 0 090000648059b3ee
FDA-1978-N-1446-0016 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Table of Contents Antiemetic TFM Administrative Record (78N-0036) Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T14:36:49Z   0 0 090000648059b3f6
FDA-1978-N-1446-0050 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Memorandum of Telephone Conversation between William H. Rorer, Inc. and OTC Drug Evaluation (CDER) Other Memorandum 2016-06-30T04:00:00Z 2016 6 2016-06-30T04:00:00Z   2016-06-30T19:09:48Z   0 0 090000648059b3f4
FDA-1978-N-1446-0047 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Memorandum of Telephone Conversation between William H. Rorer, Inc. and FDA Other Memorandum 2016-06-30T04:00:00Z 2016 6 2016-06-30T04:00:00Z   2016-06-30T18:43:39Z   0 0 090000648059b3f1
FDA-1978-N-1446-0032 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Attachment 2 Consumer Survey on Symptoms of Upset Stomach re: Comment from Norwich-Eaton Pharmaceuticals Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:39:28Z   0 0 0900006482053dad
FDA-1978-N-1446-0045 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Table of Contents re: Citizen Petition from William H. Rorer, Inc. Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T18:40:33Z   0 0 0900006482058041
FDA-1978-N-1446-0027 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Attachment 8 Studies in Motion Sickness as Related to Commercial Aviation Aero Medical Association May 14-17, 1951 re: Comment from Searle Lab, Inc. Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:14:19Z   0 0 0900006482050d22
FDA-1978-N-1446-0046 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Certification Statement from William H. Rorer, Inc. Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T18:41:44Z   0 0 090000648059b3f0
FDA-1978-N-1446-0021 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Tab 5 Memorandum of Telephone Conversation (July 2, 1978) between Ronald F. Panner (William H. Rorer, Inc.) and FDA re: Antiemetic TFM Administrative Record (78N-0036) 44FR41064 Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T14:49:08Z   0 0 090000648205785a
FDA-1978-N-1446-0040 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Memorandum of Telephone Conference between FDA and William H. Rorer, Inc., Other Memorandum 2016-06-30T04:00:00Z 2016 6 2016-06-30T04:00:00Z   2016-06-30T16:24:12Z   0 0 090000648059b3ea
FDA-1978-N-1446-0022 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Objection from William H. Rorer Inc., Other Objection(s) 2016-06-30T04:00:00Z 2016 6 2016-06-30T04:00:00Z   2016-06-30T14:57:10Z   0 0 090000648059b3e0
FDA-1978-N-1446-0015 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Memorandum from OTC Drug Evaluation (CDER) to Dockets Other Memorandum 2016-06-30T04:00:00Z 2016 6 2016-06-30T04:00:00Z   2016-06-30T14:35:13Z   0 0 090000648205733c
FDA-1978-N-1446-0033 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Supplement from William H. Rorer, Inc. Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T16:00:53Z   0 0 090000648059b3ed
FDA-1978-N-1446-0031 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Attachment 1 Part 336 Antiemetic, Antinauseant Drug Products for Over-the-Counter Human Use re: Comment from Norwich-Eaton Pharmaceuticals Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:38:01Z   0 0 0900006482053dac
FDA-1978-N-1446-0019 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Tab 3 Statement of Exemption and Environmental Assessment Report for the Establishment of a Tentative Final Monograph for OTC Antiemetic Drug Products re: Antiemetic TFM Administrative Record (78N-0036) 44FR41064 Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T14:47:18Z   0 0 0900006482057858
FDA-1978-N-1446-0051 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Antiemetic Drug Products for Over-the-Counter Human Use; Final Monograph Notice Notice of Final Rule 2016-06-30T04:00:00Z 2016 6 2016-06-30T04:00:00Z 1988-05-03T03:59:59Z 2016-06-30T19:11:42Z   0 0 090000648059b3f5
FDA-1978-N-1446-0043 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Citizen Petition from William H. Rorer, Inc. Other Citizen Petition 2016-06-30T04:00:00Z 2016 6 2016-06-30T04:00:00Z   2016-06-30T16:33:49Z   0 0 090000648059b3ef
FDA-1978-N-1446-0029 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Answer from FDA OTC Drug Evaluation (CDER) to William H. Rorer, Inc., Other Answer 2016-06-30T04:00:00Z 2016 6 2016-06-30T04:00:00Z   2016-06-30T15:28:41Z   0 0 0900006482051eb7
FDA-1978-N-1446-0048 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Petition Approval Letter from FDA OC to William H. Rorer, Inc. Other Approval 2016-06-30T04:00:00Z 2016 6 2016-06-30T04:00:00Z   2016-06-30T18:53:10Z   0 0 090000648059b3f2
FDA-1978-N-1446-0049 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Letter from FDA OTC Drug Evaluation (CDER) to William H. Rorer, Inc. Other Letter(s) 2016-06-30T04:00:00Z 2016 6 2016-06-30T04:00:00Z   2016-06-30T18:55:33Z   0 0 090000648059b3f3
FDA-1978-N-1446-0020 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Tab 4 Letter (December 29, 1977) from N. D. Hightower, M.D. to FDA re: Antiemetic TFM Administrative Record (78N-0036) 44FR41064 Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T14:48:11Z   0 0 0900006482057859
FDA-1978-N-1446-0044 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Acknowledgment Letter from FDA DDM to William H. Rorer, Inc. Other Acknowledgement Letter/Receipt 2016-06-30T04:00:00Z 2016 6 2016-06-30T04:00:00Z   2016-06-30T16:45:30Z   0 0 0900006482058680
FDA-1978-N-1446-0023 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Objection from Searle Lab Inc., Other Objection(s) 2016-06-30T04:00:00Z 2016 6 2016-06-30T04:00:00Z   2016-06-30T15:00:30Z   0 0 090000648059b3e1
FDA-1978-N-1446-0026 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Memorandum of Telephone Conversation between William H. Rohrer, Inc. and OTC Drug Evaluation (CDER) Other Memorandum 2016-06-30T04:00:00Z 2016 6 2016-06-30T04:00:00Z   2016-06-30T15:10:12Z   0 0 090000648059b3e6
FDA-1978-N-1446-0034 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Table of Contents Appendices A-D re: Comment from Norwich-Eaton Pharmaceuticals Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:49:24Z   0 0 0900006482053e53
FDA-1978-N-1446-0035 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Introduction re: Comment from Norwich-Eaton Pharmaceuticals Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:50:09Z   0 0 0900006482053e54
FDA-1978-N-1446-0017 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Tab 1 Minutes of the Seventh Meeting of the Neurologic Drugs Advisory Committee (June 27-28,1977) re: Antiemetic TFM Administrative Record (78N-0036) 44FR41064 Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T14:45:14Z   0 0 0900006482057856
FDA-1978-N-1446-0008 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Attachment 5 Chinn, Noell and Smith Prophylaxis of Motion Sickness Arch. Int. Med. 86: pgs 810-822 Dec. 1950 re: Comment from Searle Lab, Inc. Supporting & Related Material Background Material 2016-06-29T04:00:00Z 2016 6     2016-06-29T19:02:34Z   0 0 0900006482050b87
FDA-1978-N-1446-0005 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Attachment 2 Federal Register Notice Drugs for Human Use; Drug Efficacy Study Implementation re: Comment from Searle Lab, Inc. Supporting & Related Material Background Material 2016-06-29T04:00:00Z 2016 6     2016-06-29T18:59:03Z   0 0 0900006482050744
FDA-1978-N-1446-0009 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Attachment 6 Report of Study by Army, Navy, Air Force Motion Sickness Team Evaluation of Drugs for Protection Against Motion Sickness aborad Transport Ships pgs. 755-760 re: Comment from Searle Lab, Inc. Supporting & Related Material Background Material 2016-06-29T04:00:00Z 2016 6     2016-06-29T19:03:34Z   0 0 0900006482050b8b
FDA-1978-N-1446-0014 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Animal Safety Study/Report from Commerce Drug Co. Inc., (McMurray and Pendergast) re: Acute Oral Toxiciity Supporting & Related Material Background Material 2016-06-29T04:00:00Z 2016 6     2016-06-30T14:17:54Z   0 0 090000648059b3dd
FDA-1978-N-1446-0007 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Attachment 4 Gay and Carliner The Prevention and Treatment of Motion Sickness pgs. 470-487 John Hopkins Hosp. re: Comment from Searle Lab, Inc. Supporting & Related Material Background Material 2016-06-29T04:00:00Z 2016 6     2016-06-29T19:01:43Z   0 0 0900006482050b84
FDA-1978-N-1446-0004 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Attachment 1 Letters of Support to Searle Laboratories re: Comment from Searle Lab, Inc. Supporting & Related Material Background Material 2016-06-29T04:00:00Z 2016 6     2016-06-29T18:58:02Z   0 0 0900006482050743
FDA-1978-N-1446-0013 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Antiemetic Drug Products for Over-the-Counter Human Use; Tentative Final Order Notice Notice of Tentative Final Order 2016-06-29T04:00:00Z 2016 6 1979-07-13T04:00:00Z 1979-08-14T03:59:59Z 2016-07-09T20:29:50Z 1979-21600 0 0 090000648059b3d3
FDA-1978-N-1446-0006 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Attachment 3 Letter from Federal Security Agency (FDA) to G.D. Searle and Company re: Comment from Searle Lab, Inc. Supporting & Related Material Background Material 2016-06-29T04:00:00Z 2016 6     2016-06-29T19:00:26Z   0 0 0900006482050b34
FDA-1978-N-1446-0001 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Proposal to Establish Monographs for OTC Laxative, Antidiarrheal, Emetic, and Antiemetic Products Proposed Rule Notice of Proposed Rulemaking (NPRM) 2016-06-29T04:00:00Z 2016 6 1975-03-21T04:00:00Z 1975-04-21T03:59:59Z 2016-07-01T01:00:43Z   0 0 09000064820500d4
FDA-1978-N-1446-0010 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Attachment 9 Acknowledgment Letter from FDA to Searle Laboratories re: Comment from Searle Lab, Inc. Supporting & Related Material Background Material 2016-06-29T04:00:00Z 2016 6     2016-06-29T19:05:41Z   0 0 0900006482050d25
FDA-1978-N-1446-0011 FDA O. T. C. Antiemetic - Closed FDA-1978-N-1446 Amendment from Searle Labs, Inc. Other Amendment 2016-06-29T04:00:00Z 2016 6 2016-06-29T04:00:00Z   2016-06-29T19:07:14Z   0 0 090000648059b3db

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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);