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FDA NDA · NDA021463

FORTESTA

Sponsor: ENDO OPERATIONS

APPLICATION
NDA021463
TYPE
NDA
ORIGINAL APPROVAL
2010-12-29
LATEST ACTION
2025-07-11
ROUTE
TRANSDERMAL
DOSAGE FORM
GEL, METERED
MARKETING STATUS
Discontinued

Products

FORTESTA · ReferenceDiscontinued
TESTOSTERONE 10MG/0.5GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · GEL, METERED · TRANSDERMAL

Approval history

2025-07-11Labeling · Supplement 29 · standard — Label ↗AP
2020-06-30Labeling · Supplement 25 · standard — Letter ↗AP
2020-03-13Labeling · Supplement 22 · standard — Label ↗AP
2019-05-30REMS · Supplement 21 — Letter ↗AP
2019-05-10Labeling · Supplement 20 · standard — Letter ↗AP
2016-10-25Labeling · Supplement 19 · standard — Letter ↗AP
2016-03-10Manufacturing (CMC) · Supplement 18 · standard — Label ↗AP
2015-05-11Labeling · Supplement 17 · standard — Label ↗AP
2014-07-31REMS · Supplement 15 — Letter ↗AP
2014-06-19Labeling · Supplement 14 · standard — Label ↗AP
2014-06-04Manufacturing (CMC) · Supplement 13 · standardAP
2014-03-24Labeling · Supplement 12 · standard — Letter ↗AP
2013-11-26Manufacturing (CMC) · Supplement 11 · standardAP
2013-09-11REMS · Supplement 10 — Label ↗AP
2013-09-09Manufacturing (CMC) · Supplement 9 · standardAP
2010-12-29Type 3 - New Dosage Form · Original · standard — Letter ↗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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