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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

24 rows where agency_id = "FDA", docket_id = "FDA-1975-N-0336" and posted_year = 2021 sorted by posted_date descending

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document_type 2

  • Other 23
  • Notice 1

posted_year 1

  • 2021 · 24 ✖

agency_id 1

  • FDA · 24 ✖
id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-1975-N-0336-0102 FDA 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

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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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