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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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