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FDA NDA · NDA022309

TESTOSTERONE

Sponsor: BESINS HLTHCARE

APPLICATION
NDA022309
TYPE
NDA
ORIGINAL APPROVAL
2011-04-29
LATEST ACTION
2025-07-11
ROUTE
TRANSDERMAL
DOSAGE FORM
GEL, GEL, METERED
MARKETING STATUS
Prescription

Products

ANDROGEL · ReferencePrescription
TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) · GEL · TRANSDERMAL
ANDROGEL · ReferencePrescription
TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) · GEL, METERED · TRANSDERMAL
ANDROGEL · ReferencePrescription
TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) · GEL · TRANSDERMAL

Approval history

2025-07-11Labeling · Supplement 22 · standard — Label ↗AP
2019-05-30REMS · Supplement 21 — Letter ↗AP
2019-05-10Labeling · Supplement 20 · standard — Letter ↗AP
2019-02-25Labeling · Supplement 18 · standard — Letter ↗AP
2016-10-25Labeling · Supplement 17 · standard — Letter ↗AP
2015-08-17Manufacturing (CMC) · Supplement 15 · standardAP
2015-06-11Manufacturing (CMC) · Supplement 13 · standardAP
2015-05-11Labeling · Supplement 14 · standard — Letter ↗AP
2014-11-14Labeling · Supplement 11 · standard — Letter ↗AP
2014-06-19Labeling · Supplement 12 · standard — Label ↗AP
2014-02-28Manufacturing (CMC) · Supplement 10 · standardAP
2013-05-20Labeling · Supplement 8 · standard — Label ↗AP
2013-03-13Manufacturing (CMC) · Supplement 5 · standardAP
2013-03-12Labeling · Supplement 7 · standard — Letter ↗AP
2012-11-19Manufacturing (CMC) · Supplement 3 · standardAP
2012-09-07Labeling · Supplement 1 · unknown — Label ↗AP
2011-04-29Type 3 - New Dosage Form · Original · standard — Label ↗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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