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28 rows where docket_id = "FDA-1998-P-0083" sorted by posted_date descending
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document_type 3
agency_id 1
- FDA 28
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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| FDA-1998-P-0083-0025 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | Answer Letter from FDA CDER to American Board of Obstetrics & Gynecology | Other | Answer | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-06-12T00:23:26Z | 0 | 0 | 09000064b931e98f | ||
| FDA-1998-P-0083-0021 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | Answer Letter from FDA CDER to Health Decisions, Inc. | Other | Answer | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-06-12T00:12:43Z | 0 | 0 | 09000064b931dd34 | ||
| FDA-1998-P-0083-0031 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | Answer Letter from FDA CDER to Edward L. Klaiber, M.D. | Other | Answer | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-06-12T00:29:12Z | 0 | 0 | 09000064b931e2f6 | ||
| FDA-1998-P-0083-0029 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | Answer Letter from FDA CDER to Harvard Medical School | Other | Answer | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-06-12T00:27:25Z | 0 | 0 | 09000064b931e2f0 | ||
| FDA-1998-P-0083-0019 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | Answer Letter from FDA CDER to Morris Notelovitz M.D., Ph.D. | Other | Answer | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-06-12T00:08:49Z | 0 | 0 | 09000064b931dd31 | ||
| FDA-1998-P-0083-0039 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | Answer Letter from FDA CDER to General Clinical Research Center | Other | Answer | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-06-12T01:03:59Z | 0 | 0 | 09000064b931ecf0 | ||
| FDA-1998-P-0083-0033 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | Answer Letter from FDA CDER to George Washington University | Other | Answer | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-06-12T00:31:56Z | 0 | 0 | 09000064b931e2f9 | ||
| FDA-1998-P-0083-0023 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | Answer Letter from FDA CDER to Massachusetts General Hospital - Vincent Memorial Hospital | Other | Answer | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-06-12T00:17:24Z | 0 | 0 | 09000064b931de20 | ||
| FDA-1998-P-0083-0015 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | Acknowledgement Letter from FDA DMB to Solvay Pharmaceuticals | Other | Acknowledgement Letter/Receipt | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-06-12T00:02:19Z | 0 | 0 | 0900006480584b8b | ||
| FDA-1998-P-0083-0041 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | Answer Letter from FDA CDER to USC School of Medicine Women's Hospital | Other | Answer | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-06-12T01:06:51Z | 0 | 0 | 09000064b931ed33 | ||
| FDA-1998-P-0083-0027 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | Answer Letter from FDA CDER to Prime Plus, Inc. | Other | Answer | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-06-12T00:25:20Z | 0 | 0 | 09000064b931e21b | ||
| FDA-1998-P-0083-0037 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | Answer Letter from FDA CDER to Mayo Clinic | Other | Answer | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-06-12T01:02:06Z | 0 | 0 | 09000064b931e996 | ||
| FDA-1998-P-0083-0017 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | Answer Letter from FDA CDER to University of Massachusetts Dept of Obstetrics and Gynecology | Other | Answer | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-06-12T00:05:57Z | 0 | 0 | 09000064b931dd2e | ||
| FDA-1998-P-0083-0014 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | Citizen Petition from Solvay Pharmaceuticals | Other | Citizen Petition | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-06-12T00:01:41Z | 0 | 0 | 0900006480584b78 | ||
| FDA-1998-P-0083-0035 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | Answer Letter from FDA CDER to The Emory Clinic, Inc. | Other | Answer | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-06-12T00:33:31Z | 0 | 0 | 09000064b931e31e | ||
| FDA-1998-P-0083-0013 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. Tablets; Withdrawal of Hearing Requests; Final Resolution of Drug Efficacy Study Implementation 7661 | Notice | Withdrawal | 2026-05-27T04:00:00Z | 2026 | 5 | 2026-05-27T17:28:51Z | 2026-10479 | 0 | 0 | 09000064b92f3c99 | ||
| FDA-1998-P-0083-0010 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | A January 2011 Request for Confirmation of Hearing Request-Abbott | Other | Letter(s) | 2025-09-10T04:00:00Z | 2025 | 9 | 2025-09-10T04:00:00Z | 2025-09-10T22:33:18Z | 0 | 0 | 09000064b8f445d1 | ||
| FDA-1998-P-0083-0012 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | A June 2011 letter from Abbott withdrawing its hearing request | Other | Letter(s) | 2025-09-10T04:00:00Z | 2025 | 9 | 2025-09-10T04:00:00Z | 2025-09-10T22:33:30Z | 0 | 0 | 09000064b8f445cf | ||
| FDA-1998-P-0083-0011 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | A June 2011 letter from Abbott withdrawing its hearing request | Other | Letter(s) | 2025-09-10T04:00:00Z | 2025 | 9 | 2025-09-10T04:00:00Z | 2025-09-10T22:33:27Z | 0 | 0 | 09000064b8f445aa | ||
| FDA-1998-P-0083-0003 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | A June 2011 letter from Abbott withdrawing its hearing request | Other | Letter(s) | 2025-09-10T04:00:00Z | 2025 | 9 | 2025-09-10T04:00:00Z | 2025-09-10T22:33:23Z | 0 | 0 | 09000064b8f07b69 | ||
| FDA-1998-P-0083-0009 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | A May 2003 Letter from Kleinfeld, Kaplan and Becker, LLP regarding hearing request | Other | Letter(s) | 2025-08-25T04:00:00Z | 2025 | 8 | 2025-08-25T04:00:00Z | 2025-08-26T00:55:14Z | 0 | 0 | 09000064b8f16c9d | ||
| FDA-1998-P-0083-0008 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | A June 2025 Request for Confirmation of Hearing Request | Other | Letter(s) | 2025-08-19T04:00:00Z | 2025 | 8 | 2025-08-19T04:00:00Z | 2025-08-28T17:51:39Z | 0 | 0 | 09000064b8f07b77 | ||
| FDA-1998-P-0083-0006 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | A January 2011 Request for Confirmation of Hearing Request | Other | Letter(s) | 2025-08-19T04:00:00Z | 2025 | 8 | 2025-08-19T04:00:00Z | 2025-08-28T17:52:13Z | 0 | 0 | 09000064b8f07b6f | ||
| FDA-1998-P-0083-0004 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | An August 2025 letter from Syntho withdrawing its hearing request | Other | Letter(s) | 2025-08-19T04:00:00Z | 2025 | 8 | 2025-08-19T04:00:00Z | 2025-08-19T22:45:22Z | 0 | 0 | 09000064b8f07b6b | ||
| FDA-1998-P-0083-0007 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | A March 2011 letter affirming the hearing request | Other | Letter(s) | 2025-08-19T04:00:00Z | 2025 | 8 | 2025-08-19T04:00:00Z | 2025-08-19T22:45:33Z | 0 | 0 | 09000064b8f07b75 | ||
| FDA-1998-P-0083-0005 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | A May 2003 hearing request | Other | Letter(s) | 2025-08-19T04:00:00Z | 2025 | 8 | 2025-08-19T04:00:00Z | 2025-08-19T22:45:26Z | 0 | 0 | 09000064b8f07b6d | ||
| FDA-1998-P-0083-0001 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | Certain Estrogen-Androgen Combination Drugs; Drugs for Human Use; Drug Efficacy Study Implementation; Amendment and Opportunity for Hearing | Notice | NPH-Notice of Opportunity of Hearing | 2003-04-16T04:00:00Z | 2003 | 4 | 2012-09-22T18:15:24Z | 0 | 0 | 0900006480584b32 | |||
| FDA-1998-P-0083-0002 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | Reference List Certain Estrogen-Androgen Combination Drugs; Drugs for Human Use; Drug Efficacy Study Implementation; Amendment and Opportunity for Hearing - Background Material re FDA-1998-P-0083-0001 | Supporting & Related Material | Background Material | 2003-04-16T04:00:00Z | 2003 | 4 | 2012-09-22T18:34:22Z | 0 | 0 | 0900006480584bfa |
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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;