APPLICATION
ANDA204571
TYPE
ANDA
ORIGINAL APPROVAL
2015-08-05
LATEST ACTION
2025-07-15
ROUTE
TRANSDERMAL
DOSAGE FORM
GEL, METERED
MARKETING STATUS
Prescription
Products
TESTOSTERONEPrescription
TESTOSTERONE 10MG/0.5GM ACTUATION · GEL, METERED · TRANSDERMAL
Approval history
2025-07-15Labeling · Supplement 11 · standardAP
2025-06-30Labeling · Supplement 6 · standardAP
2019-06-21Labeling · Supplement 5 · standardAP
2019-06-21Labeling · Supplement 3 · 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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