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FDA ANDA · ANDA091073

TESTOSTERONE

Sponsor: ACTAVIS LABS UT INC

APPLICATION
ANDA091073
TYPE
ANDA
ORIGINAL APPROVAL
2017-09-18
LATEST ACTION
2024-02-07
ROUTE
TRANSDERMAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

TESTOSTERONEPrescription
TESTOSTERONE 50MG/5GM PACKET · GEL · TRANSDERMAL

Approval history

2024-02-07Labeling · Supplement 3 · standardAP
2024-02-07Labeling · Supplement 6 · standardAP
2019-06-21Labeling · Supplement 2 · standardAP
2017-09-18Not Applicable · OriginalLetterAP
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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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