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FDA ANDA · ANDA083976

TESTRED

Sponsor: BAUSCH

APPLICATION
ANDA083976
TYPE
ANDA
ORIGINAL APPROVAL
1973-12-03
LATEST ACTION
2025-07-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

TESTRED · ReferenceDiscontinued
METHYLTESTOSTERONE 10MG · CAPSULE · ORAL

Approval history

2025-07-11Labeling · Supplement 35 · standardAP
2016-10-25Labeling · Supplement 34 · standard — Label ↗AP
2015-05-11Labeling · Supplement 32 · standard — Label ↗AP
2014-06-19Labeling · Supplement 31 · standard — Label ↗AP
2002-11-27Labeling · Supplement 27AP
1998-08-18Manufacturing (CMC) · Supplement 26AP
1997-08-25Manufacturing (CMC) · Supplement 24AP
1997-08-25Manufacturing (CMC) · Supplement 25AP
1994-08-08Labeling · Supplement 23AP
1992-11-03Labeling · Supplement 22AP
1992-05-29Labeling · Supplement 21AP
1989-05-25Labeling · Supplement 20AP
1983-03-08Manufacturing (CMC) · Supplement 18AP
1973-12-03OriginalAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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