← FDA DRUG APPROVALS

FDA NDA · NDA021015

TESTOSTERONE

Sponsor: BESINS HLTHCARE

APPLICATION
NDA021015
TYPE
NDA
ORIGINAL APPROVAL
2000-02-28
LATEST ACTION
2025-07-11
ROUTE
TRANSDERMAL
DOSAGE FORM
GEL, GEL, METERED
MARKETING STATUS
Prescription

Products

ANDROGEL · ReferencePrescription
TESTOSTERONE 50MG/5GM PACKET · GEL · TRANSDERMAL
ANDROGEL · ReferencePrescription
TESTOSTERONE 12.5MG/1.25GM ACTUATION · GEL, METERED · TRANSDERMAL
ANDROGEL · ReferencePrescription
TESTOSTERONE 25MG/2.5GM PACKET · GEL · TRANSDERMAL

Approval history

2025-07-11Labeling · Supplement 47 · standard — Label ↗AP
2019-05-30REMS · Supplement 46 — Letter ↗AP
2019-05-10Labeling · Supplement 45 · standard — Letter ↗AP
2019-02-25Labeling · Supplement 44 · standard — Letter ↗AP
2016-10-25Labeling · Supplement 43 · standard — Letter ↗AP
2015-08-17Manufacturing (CMC) · Supplement 41AP
2015-05-11Labeling · Supplement 40 · standard — Label ↗AP
2014-11-12Labeling · Supplement 38 · standard — Label ↗AP
2014-06-19Labeling · Supplement 39 · standard — Letter ↗AP
2014-02-27Manufacturing (CMC) · Supplement 37AP
2013-05-20Labeling · Supplement 36 · standard — Label ↗AP
2012-11-19Manufacturing (CMC) · Supplement 33AP
2012-09-20Labeling · Supplement 34 · unknown — Label ↗AP
2011-11-30REMS · Supplement 32 — Letter ↗AP
2011-03-10Labeling · Supplement 28 · standard — Letter ↗AP
2009-09-18Labeling · Supplement 22 · standard — Letter ↗AP
2009-03-19Manufacturing (CMC) · Supplement 21AP
2007-12-27Labeling · Supplement 20 · standard — Letter ↗AP
2007-12-27Labeling · Supplement 19 · standard — Letter ↗AP
2007-12-13Labeling · Supplement 16 · standard — Label ↗AP
2006-07-14Manufacturing (CMC) · Supplement 14AP
2005-08-16Labeling · Supplement 13 · standard — Letter ↗AP
2005-08-11Efficacy · Supplement 11 · unknown — Letter ↗AP
2004-11-19Labeling · Supplement 12 · standard — Letter ↗AP
2003-09-26Manufacturing (CMC) · Supplement 10 — Review ↗AP
2003-09-17Labeling · Supplement 8 · standard — Review ↗AP
2002-10-22Labeling · Supplement 4 · standard — Letter ↗AP
2002-09-18Manufacturing (CMC) · Supplement 7AP
2001-09-05Labeling · Supplement 3 · standardAP
2001-08-09Manufacturing (CMC) · Supplement 6AP
2001-06-27Labeling · Supplement 5 · standardAP
2001-01-23Manufacturing (CMC) · Supplement 2AP
2000-06-07Labeling · Supplement 1 · standardAP
2000-02-28Type 3 - New Dosage Form · Original · standard — Letter ↗AP
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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