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FDA ANDA · ANDA085635

TESTOSTERONE CYPIONATE

Sponsor: PFIZER

APPLICATION
ANDA085635
TYPE
ANDA
ORIGINAL APPROVAL
1979-07-25
LATEST ACTION
2025-07-28
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

DEPO-TESTOSTERONE · ReferencePrescription
TESTOSTERONE CYPIONATE 200MG/ML · INJECTABLE · INJECTION
DEPO-TESTOSTERONEDiscontinued
TESTOSTERONE CYPIONATE 50MG/ML · INJECTABLE · INJECTION
DEPO-TESTOSTERONE · ReferencePrescription
TESTOSTERONE CYPIONATE 100MG/ML · INJECTABLE · INJECTION

Approval history

2025-07-28Manufacturing (CMC) · Supplement 28 · priority — Label ↗AP
2025-07-11Labeling · Supplement 45 · standardAP
2025-06-18Labeling · Supplement 39 · standardAP
2018-08-01Labeling · Supplement 40 · standard — Label ↗AP
2017-01-09Labeling · Supplement 38 · standardAP
2016-10-25Labeling · Supplement 35 · standardAP
2016-08-12Labeling · Supplement 32 · standardAP
2015-05-11Labeling · Supplement 30 · standard — Label ↗AP
2015-02-17Labeling · Supplement 26 · standardAP
2014-06-19Labeling · Supplement 29 · standard — Label ↗AP
2002-07-03Manufacturing (CMC) · Supplement 15AP
2002-05-28Manufacturing (CMC) · Supplement 16AP
2000-04-05Manufacturing (CMC) · Supplement 14AP
1997-04-30Labeling · Supplement 13 — Review ↗AP
1996-05-03Labeling · Supplement 12 — Review ↗AP
1991-07-11Labeling · Supplement 11 — Review ↗AP
1984-06-13Manufacturing (CMC) · Supplement 7AP
1982-11-03Manufacturing (CMC) · Supplement 5AP
1979-07-25OriginalAP
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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