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FDA NDA · NDA202763

TESTOSTERONE

Sponsor: ANI PHARMS

APPLICATION
NDA202763
TYPE
NDA
ORIGINAL APPROVAL
2012-02-14
LATEST ACTION
2016-10-25
ROUTE
TRANSDERMAL
DOSAGE FORM
GEL
MARKETING STATUS
Discontinued

Products

TESTOSTERONEDiscontinued
TESTOSTERONE 25MG/2.5GM PACKET · GEL · TRANSDERMAL
TESTOSTERONEDiscontinued
TESTOSTERONE 50MG/5GM PACKET · GEL · TRANSDERMAL

Approval history

2016-10-25Labeling · Supplement 4 · standard — Letter ↗AP
2015-05-11Labeling · Supplement 3 · standard — Label ↗AP
2014-07-23Labeling · Supplement 1 · standard — Label ↗AP
2014-06-19Labeling · Supplement 2 · standard — Label ↗AP
2012-02-14Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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