FDA NDA · NDA203098

TESTOSTERONE

Sponsor: PERRIGO ISRAEL

APPLICATION

NDA203098

TYPE

NDA

ORIGINAL APPROVAL

2013-01-31

LATEST ACTION

2016-10-25

ROUTE

TRANSDERMAL

DOSAGE FORM

GEL, GEL, METERED

MARKETING STATUS

Discontinued

Products

TESTOSTERONEDiscontinued

TESTOSTERONE 50MG/5GM PACKET · GEL · TRANSDERMAL

TESTOSTERONEDiscontinued

TESTOSTERONE 12.5MG/1.25GM ACTUATION · GEL, METERED · TRANSDERMAL

TESTOSTERONEDiscontinued

TESTOSTERONE 25MG/2.5GM PACKET · GEL · TRANSDERMAL

2016-10-25Labeling · Supplement 9 · standard — Letter ↗AP

2016-02-26Manufacturing (CMC) · Supplement 7 · standardAP

2015-05-11Labeling · Supplement 6 · standard — Label ↗AP

2015-05-01Manufacturing (CMC) · Supplement 1 · standardAP

2015-02-03Manufacturing (CMC) · Supplement 4 · standardAP

2014-06-19Labeling · Supplement 2 · 901 required — Label ↗AP

2013-01-31Type 3 - New Dosage Form · Original · standard — Letter ↗AP

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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