← FDA DRUG APPROVALS

FDA NDA · NDA021454

TESTIM

testosterone

Sponsor: ENDO OPERATIONS

APPLICATION
NDA021454
TYPE
NDA
ORIGINAL APPROVAL
2002-10-31
LATEST ACTION
2025-07-11
ROUTE
TRANSDERMAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

TESTIM · ReferencePrescription
TESTOSTERONE 50MG/5GM PACKET · GEL · TRANSDERMAL

Approval history

2025-07-11Labeling · Supplement 36 · standard — Label ↗AP
2021-08-20Labeling · Supplement 25 · standard — Label ↗AP
2021-08-20Labeling · Supplement 34 · standard — Label ↗AP
2020-11-30Labeling · Supplement 31 · standard — Label ↗AP
2020-11-30Labeling · Supplement 30 · standard — Label ↗AP
2019-05-30REMS · Supplement 29 — Letter ↗AP
2019-05-10Labeling · Supplement 27 · standard — Letter ↗AP
2016-10-25Labeling · Supplement 24 · standard — Letter ↗AP
2015-05-11Labeling · Supplement 23 · 901 required — Letter ↗AP
2015-04-09Manufacturing (CMC) · Supplement 22 · standardAP
2014-06-19Labeling · Supplement 21 · standard — Label ↗AP
2014-05-01REMS · Supplement 20 — Letter ↗AP
2014-01-02Manufacturing (CMC) · Supplement 19 · standardAP
2013-08-30Labeling · Supplement 16 · standard — Letter ↗AP
2011-11-22REMS · Supplement 14 — Label ↗AP
2009-09-18Labeling · Supplement 8 · standard — Letter ↗AP
2002-10-31Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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