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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

31 rows where docket_id = "FDA-1975-N-0336" and posted_year = 2011 sorted by posted_date descending

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  • 2011 · 31 ✖

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  • Other 31

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  • FDA 31
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0336-0031 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
FDA-1975-N-0336-0012 FDA Drugs Containing Anticholinergic/Antispasmodic Combination FDA-1975-N-0336 FDA/CDERLletter to Lemmon Co., DESI 597 - [ Teva Pharmaceuticals Co.] - Letter Other Letter(s) 2011-08-29T04:00:00Z 2011 8 2011-08-29T04:00:00Z   2024-11-12T05:02:18Z   1 0 0900006480f076b7
FDA-1975-N-0336-0006 FDA Drugs Containing Anticholinergic/Antispasmodic Combination FDA-1975-N-0336 FDA/CDER Letter to Carter-Wallace, Inc., DESI 597 - [ Kleinfeld, Kaplan & Becker LLP] - Letter Other Letter(s) 2011-08-29T04:00:00Z 2011 8 2011-08-29T04:00:00Z   2011-08-30T19:33:06Z   0 0 0900006480f07671
FDA-1975-N-0336-0007 FDA Drugs Containing Anticholinergic/Antispasmodic Combination FDA-1975-N-0336 FDA/CDER Letter to Ferdale Pharma Group, Inc - Letter Other Letter(s) 2011-08-29T04:00:00Z 2011 8 2011-08-29T04:00:00Z   2011-08-30T19:33:22Z   0 0 0900006480f07678
FDA-1975-N-0336-0013 FDA Drugs Containing Anticholinergic/Antispasmodic Combination FDA-1975-N-0336 FDA/CDER letter to McNeil Pharmaceuticals., DESI 597 - [ Ortho-McNeil-Janssen Pharmaceuticals Inc.] - Letter Other Letter(s) 2011-08-29T04:00:00Z 2011 8 2011-08-29T04:00:00Z   2011-08-30T19:37:33Z   0 0 0900006480f076ba
FDA-1975-N-0336-0009 FDA Drugs Containing Anticholinergic/Antispasmodic Combination FDA-1975-N-0336 FDA/CDER letter to Halsey Drug Co. - [ Acura Pharmaceuticals Co.] - Letter Other Letter(s) 2011-08-29T04:00:00Z 2011 8 2011-08-29T04:00:00Z   2024-11-07T22:36:38Z   1 0 0900006480f076a0
FDA-1975-N-0336-0011 FDA Drugs Containing Anticholinergic/Antispasmodic Combination FDA-1975-N-0336 FDA/CDER Letter to Lemmon Co., DESI 597 - [ Teva Pharmaceuticals Co.] - Letter Other Letter(s) 2011-08-29T04:00:00Z 2011 8 2011-08-29T04:00:00Z   2024-11-07T22:36:30Z   1 0 0900006480f076b2
FDA-1975-N-0336-0008 FDA Drugs Containing Anticholinergic/Antispasmodic Combination FDA-1975-N-0336 FDA/CDER Letter to Halsey Drug Co., DESI 597 - [ Acura Pharmaceuticals Co.] - Letter Other Letter(s) 2011-08-29T04:00:00Z 2011 8 2011-08-29T04:00:00Z   2011-08-30T19:33:37Z   0 0 0900006480f0767c
FDA-1975-N-0336-0010 FDA Drugs Containing Anticholinergic/Antispasmodic Combination FDA-1975-N-0336 FDA/CDER letter to Kremers-Urban Co. DESI 597 - [ Kleinfeld, Kaplan & Becker LLP] - Letter Other Letter(s) 2011-08-29T04:00:00Z 2011 8 2011-08-29T04:00:00Z   2024-11-07T22:36:30Z   1 0 0900006480f076a2
FDA-1975-N-0336-0005 FDA Drugs Containing Anticholinergic/Antispasmodic Combination FDA-1975-N-0336 Letter from FDA CDER to Kleindeld, Kaplan & Becker LLP Other Letter(s) 2011-08-25T04:00:00Z 2011 8 2011-08-25T04:00:00Z   2017-11-13T18:35:08Z   0 0 0900006480eeb8ed
FDA-1975-N-0336-0004 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 (Buchanan Ingersoll & Rooney PC) (Vol 141-A) Other Request for Hearing 2011-08-11T04:00:00Z 2011 8 2011-08-11T04:00:00Z   2017-12-05T21:41:21Z   0 0 0900006480ec1a8d
FDA-1975-N-0336-0003 FDA Drugs Containing Anticholinergic/Antispasmodic Combination FDA-1975-N-0336 FDA/OC to PMB Pharmaceuticals, Inc.(Buchanan Ingersoll & Rooney, PC) - Letter Other Letter(s) 2011-08-09T04:00:00Z 2011 8 2011-08-09T04:00:00Z   2011-08-09T19:57:46Z   0 0 0900006480edc698
FDA-1975-N-0336-0001 FDA Drugs Containing Anticholinergic/Antispasmodic Combination FDA-1975-N-0336 Letter from West-Ward Pharmaceutical Corporation and PBM Pharmaceutical, Inc. to FDA/CDER Other Letter(s) 2011-07-14T04:00:00Z 2011 7 2011-07-14T04:00:00Z   2017-12-06T15:37:11Z   0 0 0900006480ebd5c8
FDA-1975-N-0336-0002 FDA Drugs Containing Anticholinergic/Antispasmodic Combination FDA-1975-N-0336 Letter from PBM Pharmaceutical, Inc. (Buchanan Ingersoll and Rooney, PC) to FDA Other Letter(s) 2011-07-14T04:00:00Z 2011 7 2011-07-14T04:00:00Z   2017-12-06T15:54:22Z   0 0 0900006480ebd5ca

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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