documents

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

23 rows where docket_id = "FDA-1993-P-0037" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1993-P-0037-0031 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Petition Denial from FDA CDER to Wiley, Rein & Fielding Other Denial 2014-03-07T05:00:00Z 2014 3 2014-03-07T05:00:00Z   2025-01-28T16:15:12Z   0 0 09000064804fbef6
FDA-1993-P-0037-0030 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Tab A 1- 2 - Mylan Pharmaceuticals, Inc. - [Wiley, Rein & Fielding - Petition for Stay] Other PSA-Petition for Stay 2010-05-28T04:00:00Z 2010 5 2010-05-28T04:00:00Z   2010-10-29T01:01:31Z   0 0 09000064804fbec5
FDA-1993-P-0037-0024 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Tab D - Letter from Wiley, Rein & Fielding to FDA DMB re: Petition for Stay Other Background Material 2010-05-27T04:00:00Z 2010 5 2010-05-27T04:00:00Z   2025-09-19T20:05:53Z   0 0 09000064804fbea5
FDA-1993-P-0037-0027 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Points to Consider re: Petition for Stay Other Background Material 2010-05-27T04:00:00Z 2010 5 2010-05-27T04:00:00Z   2025-09-19T20:23:46Z   0 0 09000064804fbeaf
FDA-1993-P-0037-0026 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Tab F - Letter from Wiley, Rein & Fielding to FDA DMB re: Petition for Stay Other Background Material 2010-05-27T04:00:00Z 2010 5 2010-05-27T04:00:00Z   2025-09-19T20:20:53Z   0 0 09000064804fbeac
FDA-1993-P-0037-0025 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Tab E - Letter from Wiley, Rein & Fielding to FDA DMB re: Petition for Stay Other Background Material 2010-05-27T04:00:00Z 2010 5 2010-05-27T04:00:00Z   2025-09-19T20:11:52Z   0 0 09000064804fbea8
FDA-1993-P-0037-0029 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Exhibit 5 - Biopharmaceutical Considerations re: Petition for Stay Other Background Material 2010-05-27T04:00:00Z 2010 5 2010-05-27T04:00:00Z   2025-09-19T20:46:23Z   0 0 09000064804fbeba
FDA-1993-P-0037-0028 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Petition for Withdrawal or Stay from Wiley, Rein & Fielding on behalf of Pfizer Inc. Other Petition(s) 2010-05-27T04:00:00Z 2010 5 2010-05-27T04:00:00Z   2025-09-19T20:25:34Z   0 0 09000064804fbeb2
FDA-1993-P-0037-0023 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Tab 26 - Center for Drug Evaluation and Research, FDA, Tr. for Jan. 11-12, 1994 Meeting of the Generic Drug Advisory Committee Other Supplement (SUP) 2010-05-21T04:00:00Z 2010 5 2010-05-21T04:00:00Z   2025-09-19T20:01:24Z   0 0 09000064804fbe44
FDA-1993-P-0037-0021 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Tab 26 - Center for Drug Evaluation and Research, FDA, Tr. for Jan. 11-12, 1994 Meeting of the Generic Drug Advisory Committee Other Supplement (SUP) 2010-05-21T04:00:00Z 2010 5 2010-05-21T04:00:00Z   2025-09-19T19:54:49Z   0 0 09000064804fbe3a
FDA-1993-P-0037-0019 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Tab 25 - Center for Drug Evaluation and Research, FDA, Tr. for Jan. 11-12, 1994 Meeting of the Generic Drug Advisory Committee Other Supplement (SUP) 2010-05-21T04:00:00Z 2010 5 2010-05-21T04:00:00Z   2025-09-19T19:51:44Z   0 0 09000064804fbe30
FDA-1993-P-0037-0022 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Tab 26 - Center for Drug Evaluation and Research, FDA, Tr. for Jan. 11-12, 1994 Meeting of the Generic Drug Advisory Committee Other Supplement (SUP) 2010-05-21T04:00:00Z 2010 5 2010-05-21T04:00:00Z   2025-09-19T20:00:12Z   0 0 09000064804fbe3e
FDA-1993-P-0037-0020 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Tab 25 - Center for Drug Evaluation and Research, FDA, Tr. for Jan. 11-12, 1994 Meeting of the Generic Drug Advisory Committee Other Supplement (SUP) 2010-05-21T04:00:00Z 2010 5 2010-05-21T04:00:00Z   2025-09-19T19:53:01Z   0 0 09000064804fbe35
FDA-1993-P-0037-0017 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Tab 24 - Center for Drug Evaluation and Research, FDA, Summary Minutes for Jan. 11-12, 1994 Meeting of the Generic Drug Advisory Committee (June 26, 1994) Other Supplement (SUP) 2010-04-29T04:00:00Z 2010 4 2010-04-29T04:00:00Z   2025-09-19T19:48:50Z   0 0 09000064804fbe27
FDA-1993-P-0037-0016 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Supplement 2 re: Pfizer Inc. Other Supplement (SUP) 2010-04-29T04:00:00Z 2010 4 2010-04-29T04:00:00Z   2025-09-19T19:42:51Z   0 0 09000064804fbe22
FDA-1993-P-0037-0018 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Tab 25 - Center for Drug Evaluation and Research, FDA, Tr. for Jan. 11-12, 1994 Meeting of the Generic Drug Advisory Committee Other Supplement (SUP) 2010-04-29T04:00:00Z 2010 4 2010-04-29T04:00:00Z   2025-09-19T19:50:41Z   0 0 09000064804fbe2a
FDA-1993-P-0037-0005 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Supplement 1 re: Pfizer Inc. Other Supplement (SUP) 2010-04-28T04:00:00Z 2010 4 2010-04-28T04:00:00Z   2025-09-19T19:35:26Z   0 0 09000064804fbdcc
FDA-1993-P-0037-0015 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Supplement 2 re: Pfizer Inc. Other Supplement (SUP) 2010-04-28T04:00:00Z 2010 4 2010-04-28T04:00:00Z   2025-09-19T19:40:50Z   0 0 09000064804fbe48
FDA-1993-P-0037-0013 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Supplement 3 re: Pfizer Inc. Other Supplement (SUP) 2010-04-28T04:00:00Z 2010 4 2010-04-28T04:00:00Z   2025-09-19T19:33:17Z   0 0 09000064804fbea2
FDA-1993-P-0037-0008 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Letter from FDA CDER to Wiley, Rein & Fielding Other Letter(s) 2010-04-28T04:00:00Z 2010 4 2010-04-28T04:00:00Z   2025-01-28T15:16:42Z   0 0 09000064804fbddc
FDA-1993-P-0037-0003 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Citizen Petition from Wiley, Rein & Fielding on behalf of Pfizer Inc. Other Citizen Petition 2010-04-28T04:00:00Z 2010 4 2010-04-28T04:00:00Z   2025-01-28T14:56:02Z   0 0 09000064804fbda2
FDA-1993-P-0037-0004 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Exhibit 3 -Approved Drug Products with Therapeutic Equivalence Evaluations Other Exhibit(s) 2010-04-28T04:00:00Z 2010 4 2010-04-28T04:00:00Z   2025-09-19T19:28:51Z   0 0 09000064804fbdc0
FDA-1993-P-0037-0002 FDA Modify ANDA Suitability Petition Processing Practices -CLOSED FDA-1993-P-0037 Acknowledgement Letter from FDA DMB to Wiley, Rein & Fielding Other Acknowledgement Letter/Receipt 1997-07-02T04:00:00Z 1997 7     2025-01-28T14:48:40Z   0 0 09000064804fbefb

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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);