Nonrulemaking

Withdrawn From Sale of Tylosterone Tablets

🏛 Food and Drug Administration (FDA)FDA-1998-P-0083

Pharmaceutical Policy Product Safety & Recalls

Documents

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all analyzed

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Closed

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In this docket

Documents

Rules, notices, and supporting material — the primary rule pinned first.

All 21 Other 17 Notice 3 Supporting & Related Material 1

📄 Primary document

NoticeJun 26, 2026

Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661

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Other· Jun 18, 2026
Hearing request from Alston & Bird LLP (on behalf of ANI Pharmaceuticals, Inc.)→
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Other· Jun 18, 2026
Hearing request from Hyman, Phelps & Mcnamara, P.C. (on behalf of Syntho Pharmaceutical, Inc.)→
No comment period
Other· Jun 11, 2026
Citizen Petition from Solvay Pharmaceuticals→
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Other· Jun 11, 2026
Acknowledgement Letter from FDA DMB to Solvay Pharmaceuticals→
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Other· Jun 11, 2026
Answer Letter from FDA CDER to University of Massachusetts Dept of Obstetrics and Gynecology→
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Other· Jun 11, 2026
Answer Letter from FDA CDER to Morris Notelovitz M.D., Ph.D.→
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Other· Jun 11, 2026
Answer Letter from FDA CDER to Health Decisions, Inc.→
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Other· Jun 11, 2026
Answer Letter from FDA CDER to Massachusetts General Hospital - Vincent Memorial Hospital→
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Other· Jun 11, 2026
Answer Letter from FDA CDER to American Board of Obstetrics & Gynecology→
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Other· Jun 11, 2026
Answer Letter from FDA CDER to Prime Plus, Inc.→
No comment period
Other· Jun 11, 2026
Answer Letter from FDA CDER to Harvard Medical School→
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Other· Jun 11, 2026
Answer Letter from FDA CDER to Edward L. Klaiber, M.D.→
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Other· Jun 11, 2026
Answer Letter from FDA CDER to George Washington University→
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Other· Jun 11, 2026
Answer Letter from FDA CDER to The Emory Clinic, Inc.→
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Other· Jun 11, 2026
Answer Letter from FDA CDER to Mayo Clinic→
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Other· Jun 11, 2026
Answer Letter from FDA CDER to General Clinical Research Center→
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Other· Jun 11, 2026
Answer Letter from FDA CDER to USC School of Medicine Women's Hospital→
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Notice· May 27, 2026
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· Apr 16, 2003
Certain Estrogen-Androgen Combination Drugs; Drugs for Human Use; Drug Efficacy Study Implementation; Amendment and Opportunity for Hearing→
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Supporting & Related Material· Apr 16, 2003
Reference List re: Certain Estrogen-Androgen Combination Drugs; Drugs for Human Use; Drug Efficacy Study Implementation; Amendment and Opportunity for Hearing→