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withdrawn,object_id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-0336-0121,FDA,FDA-1975-N-0336,"Drugs for Human Use; Drug Efficacy Study Implementation; Oral Prescription Drugs Containing an Anticholinergic or Antispasmodic in Combination With a Sedative, and
Single-Entity Antispasmodic Drug Products, in Oral Dosage Form; Withdrawal of Hearing Requests; Final Resolution of Drug Efficacy Study Implementation",Notice,Announcement,2022-04-25T04:00:00Z,2022,4,2022-04-25T04:00:00Z,,2022-04-25T12:23:39Z,2022-08740,0,0,0900006485031b82
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
FDA-1975-N-0336-0094,FDA,FDA-1975-N-0336,"August 2, 1973 stipulation",Other,Additional Information,2020-10-02T04:00:00Z,2020,10,2020-10-02T04:00:00Z,,2020-10-02T18:34:22Z,,0,0,09000064848b8681
FDA-1975-N-0336-0096,FDA,FDA-1975-N-0336,"November 22, 2017 Hogan Lovells Letter (Valeant)",Other,Additional Information,2020-10-02T04:00:00Z,2020,10,2020-10-02T04:00:00Z,,2020-10-02T18:34:41Z,,0,0,09000064848b8683
FDA-1975-N-0336-0095,FDA,FDA-1975-N-0336,"May 23, 2016 to Hogan Lovells",Other,Additional Information,2020-10-02T04:00:00Z,2020,10,2020-10-02T04:00:00Z,,2020-10-02T18:34:31Z,,0,0,09000064848b8682
FDA-1975-N-0336-0093,FDA,FDA-1975-N-0336,"January 2, 1973 Complaint",Other,Additional Information,2020-10-02T04:00:00Z,2020,10,2020-10-02T04:00:00Z,,2020-10-02T18:34:10Z,,0,0,09000064848b7d5f
FDA-1975-N-0336-0092,FDA,FDA-1975-N-0336,"Letter from FDA CDER to ECI Pharmaceuticals, LLC.",Other,Letter(s),2020-07-08T04:00:00Z,2020,7,2020-07-08T04:00:00Z,,2020-07-08T19:48:02Z,,0,0,0900006484732879
FDA-1975-N-0336-0091,FDA,FDA-1975-N-0336,"Withdrawal from ECI Pharmaceuticals, LLC",Other,Withdrawal,2020-05-06T04:00:00Z,2020,5,2020-05-06T04:00:00Z,,2020-05-06T16:44:04Z,,0,0,090000648455643a
FDA-1975-N-0336-0090,FDA,FDA-1975-N-0336,Acknowledge Withdrawal of Request for Internal Agency Review - Virtus Pharmaceuticals LLC - Docket FDA 1975 N 0336 final,Other,Withdrawal,2020-03-26T04:00:00Z,2020,3,2020-03-26T04:00:00Z,,2020-03-26T13:13:35Z,,0,0,090000648446b5d1
FDA-1975-N-0336-0087,FDA,FDA-1975-N-0336,"Withdrawal from Virtus Pharmaceuticals OPCO II, LLC (Husch Blackwell LLP)",Other,Withdrawal,2020-01-28T05:00:00Z,2020,1,2020-01-28T05:00:00Z,,2020-01-28T15:08:46Z,,0,0,09000064842f8665
FDA-1975-N-0336-0081,FDA,FDA-1975-N-0336,Acknowledgement Letter from CDER to Valeant Pharmaceuticals North America LLC,Other,Acknowledgement Letter/Receipt,2017-10-11T04:00:00Z,2017,10,2017-10-11T04:00:00Z,,2017-11-27T16:57:22Z,,0,0,0900006482bbe15a
FDA-1975-N-0336-0080,FDA,FDA-1975-N-0336,Response Letter from Valeant Pharmaceuticals (Hogan Lovells LLP) to FDA CDER,Other,Letter(s),2017-09-26T04:00:00Z,2017,9,2017-09-26T04:00:00Z,,2017-09-26T18:54:09Z,,0,0,0900006482b7dba4
FDA-1975-N-0336-0079,FDA,FDA-1975-N-0336,"Acknowledgment Letter from FDA CDER to Virtus Pharmaceuticals OPCO II, LLC ( Buchanan Ingersoll & Rooney, PC)",Other,Acknowledgement Letter/Receipt,2017-09-05T04:00:00Z,2017,9,2017-09-05T04:00:00Z,,2017-09-05T18:32:41Z,,0,0,0900006482b03f7f
FDA-1975-N-0336-0078,FDA,FDA-1975-N-0336,"Request for Internal Agency Review from Virtus Pharmaceuticals OPCO II, LLC ( Buchanan Ingersoll & Rooney, PC)",Other,Request,2017-09-05T04:00:00Z,2017,9,2017-09-05T04:00:00Z,,2024-11-07T01:10:44Z,,1,0,0900006482b03f7e
FDA-1975-N-0336-0077,FDA,FDA-1975-N-0336,"Letter from FDA CDER to Hyman, Phelps and McNamara, P.C.",Other,Letter(s),2016-08-22T04:00:00Z,2016,8,2016-08-22T04:00:00Z,,2016-08-22T18:14:59Z,,0,0,0900006482190241
FDA-1975-N-0336-0076,FDA,FDA-1975-N-0336,"Letter from Valeant Pharmaceuticals North America, LLC to FDA/CDER",Other,Letter(s),2016-06-03T04:00:00Z,2016,6,2016-06-03T04:00:00Z,,2017-12-05T20:14:21Z,,0,0,090000648200e1ec
FDA-1975-N-0336-0075,FDA,FDA-1975-N-0336,"Letter from Hyman, Phelps and McNamara, P.C. to FDA DDM",Other,Letter(s),2016-06-01T04:00:00Z,2016,6,2016-06-01T04:00:00Z,,2016-06-01T17:46:20Z,,0,0,0900006482005b7c
FDA-1975-N-0336-0074,FDA,FDA-1975-N-0336,"FDA Notice to Docket Regarding Librax, DESI 10837",Other,Memo,2016-05-24T04:00:00Z,2016,5,2016-05-24T04:00:00Z,,2016-06-06T20:14:14Z,,0,0,0900006481fe8f19
FDA-1975-N-0336-0072,FDA,FDA-1975-N-0336,"Request for Extention from Concordia Pharmaceuticals, Inc. (Buchanan Ingersoll Rooney PC)",Other,Request for Extension,2015-05-14T04:00:00Z,2015,5,2015-05-14T04:00:00Z,,2015-05-14T19:44:56Z,,0,0,0900006481ae101d
FDA-1975-N-0336-0073,FDA,FDA-1975-N-0336,Response Letter from FDA CDER to Buchanan Ingersoll and Rooney PC,Other,Letter(s),2015-05-14T04:00:00Z,2015,5,2015-05-14T04:00:00Z,,2015-05-14T19:38:54Z,,0,0,0900006481ae101e
FDA-1975-N-0336-0071,FDA,FDA-1975-N-0336,"Letter from FDA CDER to Concordia Pharmaceuticals, Inc.",Other,Letter(s),2015-04-09T04:00:00Z,2015,4,2015-04-09T04:00:00Z,,2015-04-09T16:59:46Z,,0,0,0900006481a9826f
FDA-1975-N-0336-0070,FDA,FDA-1975-N-0336,"Supplement from PBM Pharmaceuticals, Inc.",Other,Supplement (SUP),2014-06-05T04:00:00Z,2014,6,2014-06-05T04:00:00Z,,2014-06-05T16:20:18Z,,0,0,0900006481707b02
FDA-1975-N-0336-0069,FDA,FDA-1975-N-0336,"PBM Pharmaceuticals, Inc. - Report",Other,Report,2013-10-30T04:00:00Z,2013,10,2013-10-30T04:00:00Z,,2015-01-28T13:39:09Z,,0,0,090000648142e7ed
FDA-1975-N-0336-0062,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Phenobarbital_With_Atropine_597,Other,Studies,2013-03-28T04:00:00Z,2013,3,2013-03-28T04:00:00Z,,2013-03-28T14:46:03Z,,0,0,090000648124a813
FDA-1975-N-0336-0066,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Robinol_PH_And_Robinol_PH_Forte_12_950,Other,Studies,2013-03-28T04:00:00Z,2013,3,2013-03-28T04:00:00Z,,2013-03-28T14:48:22Z,,0,0,090000648124a999
FDA-1975-N-0336-0061,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Pamine_PB_Elixir_9_261,Other,Studies,2013-03-28T04:00:00Z,2013,3,2013-03-28T04:00:00Z,,2013-03-28T14:45:31Z,,0,0,090000648124a810
FDA-1975-N-0336-0052,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Cantil_With_PB_10_679,Other,Studies,2013-03-28T04:00:00Z,2013,3,2013-03-28T04:00:00Z,,2013-03-28T14:40:35Z,,0,0,090000648124a365
FDA-1975-N-0336-0048,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Bentyl_Repeat_Action_Tablets_With_Phenobarbital_9_311,Other,Studies,2013-03-28T04:00:00Z,2013,3,2013-03-28T04:00:00Z,,2013-03-28T14:37:32Z,,0,0,090000648124a318
FDA-1975-N-0336-0047,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Valpin PB_Elixir_13-431,Other,Studies,2013-03-28T04:00:00Z,2013,3,2013-03-28T04:00:00Z,,2013-03-28T14:36:59Z,,0,0,090000648124a316
FDA-1975-N-0336-0064,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Profenil_With_Phenobarbital_6_471,Other,Studies,2013-03-28T04:00:00Z,2013,3,2013-03-28T04:00:00Z,,2013-03-28T14:47:22Z,,0,0,090000648124a997
FDA-1975-N-0336-0051,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Bentyl_Syrup_With_Phenobarbital_7_961,Other,Studies,2013-03-28T04:00:00Z,2013,3,2013-03-28T04:00:00Z,,2013-03-28T14:40:08Z,,0,0,090000648124a31e
FDA-1975-N-0336-0055,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_CO_Elorine_8_919,Other,Studies,2013-03-28T04:00:00Z,2013,3,2013-03-28T04:00:00Z,,2013-03-28T14:42:07Z,,0,0,090000648124a784
FDA-1975-N-0336-0054,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Centrine_With_Phenobarbital_9_288,Other,Studies,2013-03-28T04:00:00Z,2013,3,2013-03-28T04:00:00Z,,2013-03-28T14:41:36Z,,0,0,090000648124a369
FDA-1975-N-0336-0060,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Nactisol_12_741,Other,Studies,2013-03-28T04:00:00Z,2013,3,2013-03-28T04:00:00Z,,2013-03-28T14:45:04Z,,0,0,090000648124a80e
FDA-1975-N-0336-0068,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Tricolid_Tablets_8_910,Other,Studies,2013-03-28T04:00:00Z,2013,3,2013-03-28T04:00:00Z,,2013-03-28T14:49:30Z,,0,0,090000648124aa24
FDA-1975-N-0336-0049,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Antrenyl_Bromide_8_492,Other,Studies,2013-03-28T04:00:00Z,2013,3,2013-03-28T04:00:00Z,,2013-03-28T14:39:00Z,,0,0,090000648124a31a
FDA-1975-N-0336-0057,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Daricon_PB_Tablets_13_515,Other,Studies,2013-03-28T04:00:00Z,2013,3,2013-03-28T04:00:00Z,,2013-03-28T14:43:47Z,,0,0,090000648124a788
FDA-1975-N-0336-0067,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Tral_With_Phenobarbital_10_599,Other,Studies,2013-03-28T04:00:00Z,2013,3,2013-03-28T04:00:00Z,,2013-03-28T14:49:05Z,,0,0,090000648124a99d
FDA-1975-N-0336-0063,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Piptal_PHB_9_427,Other,Studies,2013-03-28T04:00:00Z,2013,3,2013-03-28T04:00:00Z,,2013-03-28T14:46:29Z,,0,0,090000648124a868
FDA-1975-N-0336-0059,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Mondral_Bromide_9_032,Other,Studies,2013-03-28T04:00:00Z,2013,3,2013-03-28T04:00:00Z,,2013-03-28T14:44:39Z,,0,0,090000648124a80c
FDA-1975-N-0336-0058,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Metropine_With_Phenobarbital_4_298,Other,Studies,2013-03-28T04:00:00Z,2013,3,2013-03-28T04:00:00Z,,2013-03-28T14:44:13Z,,0,0,090000648124a78a
FDA-1975-N-0336-0050,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Bently_10_MGM_Capsules_With_Phenobarbital_7_409,Other,Studies,2013-03-28T04:00:00Z,2013,3,2013-03-28T04:00:00Z,,2013-03-28T14:39:36Z,,0,0,090000648124a31c
FDA-1975-N-0336-0056,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Dactil_With_Phenobarbital_8_907,Other,Studies,2013-03-28T04:00:00Z,2013,3,2013-03-28T04:00:00Z,,2013-03-28T14:43:19Z,,0,0,090000648124a786
FDA-1975-N-0336-0053,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Centrine_Elixir_8885,Other,Studies,2013-03-28T04:00:00Z,2013,3,2013-03-28T04:00:00Z,,2013-03-28T14:41:08Z,,0,0,090000648124a367
FDA-1975-N-0336-0065,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Pro_Banthine_With_Phenobarbital_9-014,Other,Studies,2013-03-28T04:00:00Z,2013,3,2013-03-28T04:00:00Z,,2013-03-28T14:47:57Z,,0,0,090000648124a86c
FDA-1975-N-0336-0040,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Banthine_with_Phenobarbital_7_390,Other,Studies,2013-03-27T04:00:00Z,2013,3,,,2013-03-27T20:56:20Z,,0,0,0900006481247f62
FDA-1975-N-0336-0046,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Trocinate _6_098,Other,Studies,2013-03-27T04:00:00Z,2013,3,2013-03-27T04:00:00Z,,2013-03-27T20:58:45Z,,0,0,0900006481248603
FDA-1975-N-0336-0044,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Pathilion_Tridihexethyl_Chloride_with_Phenobarbital_Sequels_11_940,Other,Studies,2013-03-27T04:00:00Z,2013,3,2013-03-27T04:00:00Z,,2013-03-27T20:57:52Z,,0,0,090000648124801e
FDA-1975-N-0336-0043,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Pamine_PB_Tablets_8-942,Other,Studies,2013-03-27T04:00:00Z,2013,3,2013-03-27T04:00:00Z,,2013-03-27T20:57:30Z,,0,0,0900006481247ff4
FDA-1975-N-0336-0041,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Bentyl_Injection_20mg_per_2cc_8-370,Other,Studies,2013-03-27T04:00:00Z,2013,3,2013-03-27T04:00:00Z,,2013-03-27T20:56:41Z,,0,0,0900006481247f6a
FDA-1975-N-0336-0042,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Pamine_PB_Drops_9-260,Other,Studies,2013-03-27T04:00:00Z,2013,3,2013-03-27T04:00:00Z,,2013-03-27T20:57:06Z,,0,0,0900006481247fad
FDA-1975-N-0336-0045,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Tral_with_Phenobarbital_11_200,Other,Studies,2013-03-27T04:00:00Z,2013,3,2013-03-27T04:00:00Z,,2013-03-27T20:58:17Z,,0,0,090000648124804d
FDA-1975-N-0336-0039,FDA,FDA-1975-N-0336,NAS_NRC_Drug_Efficacy_Study_for_Valpin_Pb_Tablets_and_Blixir,Other,Studies,2013-03-27T04:00:00Z,2013,3,,,2013-03-27T20:55:43Z,,0,0,0900006481247ef7
FDA-1975-N-0336-0037,FDA,FDA-1975-N-0336,"Supplement from PBM Pharmaceuticals, Inc. (Buchanan Ingersoll & Rooney PC)",Other,Supplement (SUP),2012-11-02T04:00:00Z,2012,11,2012-11-02T04:00:00Z,,2017-12-05T21:55:01Z,,0,0,090000648115a3fb
FDA-1975-N-0336-0036,FDA,FDA-1975-N-0336,"Supplemental Information from PBM Pharmaceuticals, Inc. (Buchanan Ingersoll & Rooney PC) (Vol. 141-C)",Other,Supplement (SUP),2012-10-05T04:00:00Z,2012,10,2012-10-05T04:00:00Z,,2017-12-05T21:46:35Z,,0,0,0900006481136b5a
FDA-1975-N-0336-0035,FDA,FDA-1975-N-0336,Letter from Valeant Pharmaceuticals North America LLC to FDA/CDER,Other,Letter(s),2012-10-02T04:00:00Z,2012,10,2012-10-02T04:00:00Z,,2017-12-06T15:35:36Z,,0,0,09000064810f8657
FDA-1975-N-0336-0033,FDA,FDA-1975-N-0336,Memorandum of Telecon Between Pfizer Inc. and FDA/CDER,Other,Memorandum,2012-08-30T04:00:00Z,2012,8,2012-08-30T04:00:00Z,,2012-08-30T22:19:51Z,,0,0,0900006480f2629f
FDA-1975-N-0336-0034,FDA,FDA-1975-N-0336,FDA/CDER to Buchanan Ingersoli & Rooney PC - Letter,Other,Letter(s),2012-08-30T04:00:00Z,2012,8,2012-08-30T04:00:00Z,,2012-08-30T22:20:59Z,,0,0,09000064810c97ea
FDA-1975-N-0336-0032,FDA,FDA-1975-N-0336,Drugs for Human Use; Drug Efficacy Study Implementation: Certain Prescription Drugs Offered for Various Indications; Opportunity to Affirm Outstanding Hearing Request,Notice,General Notice,2012-07-24T04:00:00Z,2012,7,2012-07-24T04:00:00Z,,2017-12-06T15:53:40Z,2012-18015,0,0,09000064810ac248
FDA-1975-N-0336-0031,FDA,FDA-1975-N-0336,Request for Hearing with Supporting Information Regarding Proposed Withdrawal of Approved Applications for Anticholinergic and Barbiturate Combination Drug Products - Supplemental Information (Vol. 141-B),Other,Request for Hearing,2011-09-13T04:00:00Z,2011,9,2011-09-13T04:00:00Z,,2017-12-05T21:44:07Z,,0,0,0900006480ee57db
FDA-1975-N-0336-0027,FDA,FDA-1975-N-0336,"FDA/CDER Letter to Premo Pharmaceutical Labs, Inc.,  - [Sheppard Mulln Richter & Hampton LLP]  DESI 10837 - Letter",Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2024-11-07T22:36:20Z,,1,0,0900006480f08fee
FDA-1975-N-0336-0015,FDA,FDA-1975-N-0336,"FDA/CDER Letter to Poythress Laboratories, Inc., DESI 597 - Letter",Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2011-08-30T19:38:48Z,,0,0,0900006480f08da7
FDA-1975-N-0336-0030,FDA,FDA-1975-N-0336,"FDA/CDER Letter to Cord Labs, Inc., - [Arent Fox LLP]  DESI 10837 - Letter",Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2011-08-30T19:49:09Z,,0,0,0900006480f08ff6
FDA-1975-N-0336-0024,FDA,FDA-1975-N-0336,"FDA/CDER Letter to Beecham Laboratories, DESI 597 - [ Kleinfeld, Kaplan & Becker LLP] - Letter",Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2011-08-30T19:46:03Z,,0,0,0900006480f08fb3
FDA-1975-N-0336-0026,FDA,FDA-1975-N-0336,FDA/CDER Letter to Premo Pharmaceutical. - [Teva Pharmaceuticals]  DESI 10837 - Letter,Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2024-11-12T05:03:05Z,,1,0,0900006480f08fb7
FDA-1975-N-0336-0017,FDA,FDA-1975-N-0336,"FDA/CDER Letter to  Reid-Provident Laboratories, Inc.'s., DESI 597  [ Abbott Laboratories] - Letter",Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2024-11-07T22:36:37Z,,1,0,0900006480f08ede
FDA-1975-N-0336-0019,FDA,FDA-1975-N-0336,"FDA/CDER Letter to Sandoz, Inc's - [ Kleinfeld, Kaplan & Becker LLP] - Letter",Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2024-11-07T22:36:31Z,,1,0,0900006480f08ee2
FDA-1975-N-0336-0023,FDA,FDA-1975-N-0336,"FDA/CDER Letter to B.F. Ascher & Co., Inc., DESI 597 - Letter",Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2024-11-12T05:03:05Z,,1,0,0900006480f08f95
FDA-1975-N-0336-0025,FDA,FDA-1975-N-0336,"FDA/CDER Letter to  Richlyn Laboratories, Inc.., - [Impax Laboratories, Inc.]  DESI 597 - Letter",Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2024-11-12T05:03:05Z,,1,0,0900006480f08fb5
FDA-1975-N-0336-0021,FDA,FDA-1975-N-0336,"FDA/CDER Letter to West-Ward Pharmaceutical Corp., DESI 597 - Letter",Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2013-01-08T03:27:35Z,,0,0,0900006480f08f91
FDA-1975-N-0336-0014,FDA,FDA-1975-N-0336,"FDA/CDER Letter to National  Pharmaceuticals Manufacturing Co.,, DESI 597 - [ Actavis US] - Letter",Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2024-11-07T22:36:30Z,,1,0,0900006480f08da5
FDA-1975-N-0336-0016,FDA,FDA-1975-N-0336,FDA/CDER Letter to Purepac Pharmaceutical's - [ Actavis ] - Letter,Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2011-08-30T19:39:08Z,,0,0,0900006480f08edc
FDA-1975-N-0336-0022,FDA,FDA-1975-N-0336,"FDA/CDER Letter to William Rorer, Inc., DESI 597 [ Sanofi-aventis U,S.] - Letter",Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2024-11-12T05:03:04Z,,1,0,0900006480f08f93
FDA-1975-N-0336-0020,FDA,FDA-1975-N-0336,"FDA/CDER Letter to Stuart Pharmaceuticals, DESI 597 - [ AstraZeneca Pharmaceuticals LP] - Letter",Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2011-08-30T19:42:14Z,,0,0,0900006480f08f8d
FDA-1975-N-0336-0028,FDA,FDA-1975-N-0336,"FDA/CDER Letter to Roche pharmaceutical, - [Genentech, Inc.] - DESI 10837 - Letter",Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2011-08-30T19:48:23Z,,0,0,0900006480f08ff0
FDA-1975-N-0336-0029,FDA,FDA-1975-N-0336,"FDA/CDER Letter to Roche Laboratories, - [Valeant Pharmaceuticals International, Inc] - DESI 10837 - Letter",Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2024-11-07T22:36:38Z,,1,0,0900006480f08ff4
FDA-1975-N-0336-0018,FDA,FDA-1975-N-0336,"FDA/CDER Letter to Sandoz, Inc's - [ Kleinfeld, Kaplan & Becker LLP] - Letter",Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2024-11-07T22:36:30Z,,1,0,0900006480f08ee0