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withdrawn,object_id FDA-1975-N-0336-0102,FDA,FDA-1975-N-0336,"Request for Extension from Carter-Wallace, Inc",Other,Request for Extension,2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:15:53Z,,0,0,09000064805c7b49 FDA-1975-N-0336-0104,FDA,FDA-1975-N-0336,"Request for Hearing from Carter-Wallace, Inc.",Other,Request for Hearing,2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:16:58Z,,0,0,09000064805c7b4c FDA-1975-N-0336-0107,FDA,FDA-1975-N-0336,"Request for Extension of Time from Hoffman-La Roche, Inc.",Other,Request for Extension,2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:18:55Z,,0,0,09000064805c7b50 FDA-1975-N-0336-0108,FDA,FDA-1975-N-0336,"Letter from Hoffmann-La Roche, Inc. to FDA/DDM",Other,Letter(s),2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:19:41Z,,0,0,09000064805c7b55 FDA-1975-N-0336-0111,FDA,FDA-1975-N-0336,"Request for Hearing from Chelsea Laboratories, Inc.",Other,Request for Hearing,2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:22:45Z,,0,0,09000064805c7b74 FDA-1975-N-0336-0112,FDA,FDA-1975-N-0336,"Letter from Cord Laboratories, Inc. to FDA/CDER",Other,Letter(s),2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:23:32Z,,0,0,09000064805c7b76 FDA-1975-N-0336-0113,FDA,FDA-1975-N-0336,"Letter from Premo Pharmaceutical Laboratories, Inc. to FDA/CDER",Other,Letter(s),2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:24:10Z,,0,0,09000064805c7b77 FDA-1975-N-0336-0114,FDA,FDA-1975-N-0336,"Withdrawal from Carter Wallace, Inc. (Kleinfeld, Kaplan and Becker)",Other,Withdrawal,2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:25:38Z,,0,0,09000064805c7bf6 FDA-1975-N-0336-0116,FDA,FDA-1975-N-0336,"Withdrawal of Request for Hearing from Zenith Laboratories, Inc.",Other,Withdrawal,2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:27:01Z,,0,0,09000064805c7c00 FDA-1975-N-0336-0117,FDA,FDA-1975-N-0336,"Withdrawal of Request for Hearing from Cord Laboratories, Inc.",Other,Withdrawal,2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:27:53Z,,0,0,09000064805c7c01 FDA-1975-N-0336-0119,FDA,FDA-1975-N-0336,Withdrawal from Sandoz,Other,Withdrawal,2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:30:27Z,,0,0,0900006484ea48a7 FDA-1975-N-0336-0097,FDA,FDA-1975-N-0336,"Letter from Premo Pharmaceutical Laboratories, Inc.",Other,Letter(s),2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:08:57Z,,0,0,09000064805c7b37 FDA-1975-N-0336-0105,FDA,FDA-1975-N-0336,"Notice of Appearance and Request for Hearing from Hoffman-La Roche, Inc.",Other,Request for Hearing,2021-12-07T05:00:00Z,2021,12,2021-12-07T05:00:00Z,,2021-12-07T16:17:34Z,,0,0,09000064805c7b4d FDA-1975-N-0336-0109,FDA,FDA-1975-N-0336,"Supplement from Premo Pharmaceutical Laboratories, Inc.",Other,Supplement (SUP),2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:21:04Z,,0,0,09000064805c7b66 FDA-1975-N-0336-0110,FDA,FDA-1975-N-0336,"Supplement from Cord Laboratories, Inc (Hamel, Park, McCabe & Saunders)",Other,Supplement (SUP),2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:22:02Z,,0,0,09000064805c7b68 FDA-1975-N-0336-0101,FDA,FDA-1975-N-0336,"Request for Hearing from Zenith Laboratories, Inc.",Other,Request for Hearing,2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:14:34Z,,0,0,09000064805c7b48 FDA-1975-N-0336-0120,FDA,FDA-1975-N-0336,Withdrawal from Teva Pharmaceuticals,Other,Withdrawal,2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:30:55Z,,0,0,0900006484ea48cc FDA-1975-N-0336-0099,FDA,FDA-1975-N-0336,"Notice of Appearance and Request for Hearing from Premo Pharmaceutical Laboratories, Inc.",Other,Request for Hearing,2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:11:38Z,,0,0,09000064805c7b46 FDA-1975-N-0336-0106,FDA,FDA-1975-N-0336,"Request for Hearing from Endo Laboratories, Inc.",Other,Request for Hearing,2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:18:13Z,,0,0,09000064805c7b4f FDA-1975-N-0336-0098,FDA,FDA-1975-N-0336,"Request for Hearing from Premo Pharmaceutical Laboratories, Inc.",Other,Request for Hearing,2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:09:43Z,,0,0,09000064805c7b38 FDA-1975-N-0336-0100,FDA,FDA-1975-N-0336,"Notice of Appearance and Request for Hearing from Cord Laboratories, Inc.",Other,Request for Hearing,2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:12:40Z,,0,0,09000064805c7b47 FDA-1975-N-0336-0103,FDA,FDA-1975-N-0336,Request for Hearing from Lederle Laboratories,Other,Request for Hearing,2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:16:36Z,,0,0,09000064805c7b4b FDA-1975-N-0336-0115,FDA,FDA-1975-N-0336,Pathibamate Tablets; Drugs for Human Use; Drug Efficacy Study Implementation; Withdrawal of Approval of New Drug Application,Notice,Withdrawal,2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:26:29Z,52 FR 22687,0,0,09000064805c7bff FDA-1975-N-0336-0118,FDA,FDA-1975-N-0336,"Withdrawal from Genentech, Inc.",Other,Withdrawal,2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:29:39Z,,0,0,0900006484ea470a