{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where docket_id = \"FDA-1975-N-0336\" sorted by posted_date descending", "rows": [["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\nSingle-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", null, "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, null, null, "2021-12-07T16:15:53Z", null, 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, null, null, "2021-12-07T16:16:58Z", null, 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, null, null, "2021-12-07T16:18:55Z", null, 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, null, null, "2021-12-07T16:19:41Z", null, 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, null, null, "2021-12-07T16:22:45Z", null, 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, null, null, "2021-12-07T16:23:32Z", null, 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, null, null, "2021-12-07T16:24:10Z", null, 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, null, null, "2021-12-07T16:25:38Z", null, 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, null, null, "2021-12-07T16:27:01Z", null, 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, null, null, "2021-12-07T16:27:53Z", null, 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, null, null, "2021-12-07T16:30:27Z", null, 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, null, null, "2021-12-07T16:08:57Z", null, 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", null, "2021-12-07T16:17:34Z", null, 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, null, null, "2021-12-07T16:21:04Z", null, 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, null, null, "2021-12-07T16:22:02Z", null, 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, null, null, "2021-12-07T16:14:34Z", null, 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, null, null, "2021-12-07T16:30:55Z", null, 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, null, null, "2021-12-07T16:11:38Z", null, 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, null, null, "2021-12-07T16:18:13Z", null, 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, null, null, "2021-12-07T16:09:43Z", null, 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, null, null, "2021-12-07T16:12:40Z", null, 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, null, null, "2021-12-07T16:16:36Z", null, 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, null, null, "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, null, null, "2021-12-07T16:29:39Z", null, 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", null, "2020-10-02T18:34:22Z", null, 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", null, "2020-10-02T18:34:41Z", null, 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", null, "2020-10-02T18:34:31Z", null, 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", null, "2020-10-02T18:34:10Z", null, 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", null, "2020-07-08T19:48:02Z", null, 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", null, "2020-05-06T16:44:04Z", null, 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", null, "2020-03-26T13:13:35Z", null, 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", null, "2020-01-28T15:08:46Z", null, 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", null, "2017-11-27T16:57:22Z", null, 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", null, "2017-09-26T18:54:09Z", null, 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", null, "2017-09-05T18:32:41Z", null, 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", null, "2024-11-07T01:10:44Z", null, 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", null, "2016-08-22T18:14:59Z", null, 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", null, "2017-12-05T20:14:21Z", null, 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", null, "2016-06-01T17:46:20Z", null, 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", null, "2016-06-06T20:14:14Z", null, 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", null, "2015-05-14T19:44:56Z", null, 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", null, "2015-05-14T19:38:54Z", null, 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", null, "2015-04-09T16:59:46Z", null, 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", null, "2014-06-05T16:20:18Z", null, 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", null, "2015-01-28T13:39:09Z", null, 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", null, "2013-03-28T14:46:03Z", null, 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", null, "2013-03-28T14:48:22Z", null, 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", null, "2013-03-28T14:45:31Z", null, 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", null, "2013-03-28T14:40:35Z", null, 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", null, "2013-03-28T14:37:32Z", null, 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", null, "2013-03-28T14:36:59Z", null, 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", null, "2013-03-28T14:47:22Z", null, 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", null, "2013-03-28T14:40:08Z", null, 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", null, "2013-03-28T14:42:07Z", null, 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", null, "2013-03-28T14:41:36Z", null, 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", null, "2013-03-28T14:45:04Z", null, 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", null, "2013-03-28T14:49:30Z", null, 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", null, "2013-03-28T14:39:00Z", null, 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", null, "2013-03-28T14:43:47Z", null, 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", null, "2013-03-28T14:49:05Z", null, 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", null, "2013-03-28T14:46:29Z", null, 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", null, "2013-03-28T14:44:39Z", null, 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", null, "2013-03-28T14:44:13Z", null, 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", null, "2013-03-28T14:39:36Z", null, 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", null, "2013-03-28T14:43:19Z", null, 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", null, "2013-03-28T14:41:08Z", null, 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", null, "2013-03-28T14:47:57Z", null, 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, null, null, "2013-03-27T20:56:20Z", null, 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", null, "2013-03-27T20:58:45Z", null, 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", null, "2013-03-27T20:57:52Z", null, 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", null, "2013-03-27T20:57:30Z", null, 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", null, "2013-03-27T20:56:41Z", null, 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", null, "2013-03-27T20:57:06Z", null, 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", null, "2013-03-27T20:58:17Z", null, 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, null, null, "2013-03-27T20:55:43Z", null, 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", null, "2017-12-05T21:55:01Z", null, 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", null, "2017-12-05T21:46:35Z", null, 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", null, "2017-12-06T15:35:36Z", null, 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", null, "2012-08-30T22:19:51Z", null, 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", null, "2012-08-30T22:20:59Z", null, 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", null, "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", null, "2017-12-05T21:44:07Z", null, 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", null, "2024-11-07T22:36:20Z", null, 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", null, "2011-08-30T19:38:48Z", null, 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", null, "2011-08-30T19:49:09Z", null, 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", null, "2011-08-30T19:46:03Z", null, 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", null, "2024-11-12T05:03:05Z", null, 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", null, "2024-11-07T22:36:37Z", null, 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", null, "2024-11-07T22:36:31Z", null, 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", null, "2024-11-12T05:03:05Z", null, 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", null, "2024-11-12T05:03:05Z", null, 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", null, "2013-01-08T03:27:35Z", null, 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", null, "2024-11-07T22:36:30Z", null, 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", null, "2011-08-30T19:39:08Z", null, 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", null, "2024-11-12T05:03:04Z", null, 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", null, "2011-08-30T19:42:14Z", null, 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", null, "2011-08-30T19:48:23Z", null, 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", null, "2024-11-07T22:36:38Z", null, 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", null, "2024-11-07T22:36:30Z", null, 1, 0, "0900006480f08ee0"]], "truncated": false, "filtered_table_rows_count": 113, "expanded_columns": [], "expandable_columns": [[{"column": "docket_id", "other_table": "dockets", "other_column": "id"}, "title"]], "columns": ["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"], "primary_keys": ["id"], "units": {}, "query": {"sql": "select 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 from documents where \"docket_id\" = :p0 order by posted_date desc limit 101", "params": {"p0": "FDA-1975-N-0336"}}, "facet_results": {"agency_id": {"name": "agency_id", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?docket_id=FDA-1975-N-0336", "results": [{"value": "FDA", "label": "FDA", "count": 113, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1975-N-0336&agency_id=FDA", "selected": false}], "truncated": false}, "document_type": {"name": "document_type", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?docket_id=FDA-1975-N-0336", "results": [{"value": "Other", "label": "Other", "count": 110, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1975-N-0336&document_type=Other", "selected": false}, {"value": "Notice", "label": "Notice", "count": 3, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1975-N-0336&document_type=Notice", "selected": false}], "truncated": false}, "posted_year": {"name": "posted_year", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?docket_id=FDA-1975-N-0336", "results": [{"value": 2011, "label": 2011, "count": 31, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1975-N-0336&posted_year=2011", "selected": false}, {"value": 2013, "label": 2013, "count": 31, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1975-N-0336&posted_year=2013", "selected": false}, {"value": 2021, "label": 2021, "count": 24, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1975-N-0336&posted_year=2021", "selected": false}, {"value": 2020, "label": 2020, "count": 8, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1975-N-0336&posted_year=2020", "selected": false}, {"value": 2012, "label": 2012, "count": 6, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1975-N-0336&posted_year=2012", "selected": false}, {"value": 2016, "label": 2016, "count": 4, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1975-N-0336&posted_year=2016", "selected": false}, {"value": 2017, "label": 2017, "count": 4, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1975-N-0336&posted_year=2017", "selected": false}, {"value": 2015, "label": 2015, "count": 3, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1975-N-0336&posted_year=2015", "selected": false}, {"value": 2014, "label": 2014, "count": 1, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1975-N-0336&posted_year=2014", "selected": false}, {"value": 2022, "label": 2022, "count": 1, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1975-N-0336&posted_year=2022", "selected": false}], "truncated": false}}, "suggested_facets": [{"name": "subtype", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1975-N-0336&_facet=subtype"}, {"name": "posted_month", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1975-N-0336&_facet=posted_month"}, {"name": "open_for_comment", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1975-N-0336&_facet=open_for_comment"}, {"name": "posted_date", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1975-N-0336&_facet_date=posted_date"}, {"name": "comment_start_date", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1975-N-0336&_facet_date=comment_start_date"}, {"name": "last_modified", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1975-N-0336&_facet_date=last_modified"}], "next": "2011-08-30T04~3A00~3A00Z,FDA-1975-N-0336-0018", "next_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1975-N-0336&_next=2011-08-30T04~3A00~3A00Z%2CFDA-1975-N-0336-0018&_sort_desc=posted_date", "private": false, "allow_execute_sql": true, "query_ms": 1746.5167809277773, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}