APPLICATION
ANDA212984
TYPE
ANDA
ORIGINAL APPROVAL
2021-11-09
LATEST ACTION
2025-12-17
ROUTE
TRANSDERMAL
DOSAGE FORM
GEL, GEL, METERED
MARKETING STATUS
Prescription
Products
TESTOSTERONEPrescription
TESTOSTERONE 25MG/2.5GM PACKET · GEL · TRANSDERMAL
TESTOSTERONEPrescription
TESTOSTERONE 50MG/5GM PACKET · GEL · TRANSDERMAL
TESTOSTERONEPrescription
TESTOSTERONE 12.5MG/1.25GM ACTUATION · GEL, METERED · TRANSDERMAL
Approval history
2025-12-17Labeling · Supplement 10 · standardAP
2021-11-09UNKNOWN · Original · standardAP
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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