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113 rows where docket_id = "FDA-1975-N-0336" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1975-N-0336-0121 FDA Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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 Drugs Containing Anticholinergic/Antispasmodic Combination 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

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