APPLICATION
ANDA205328
TYPE
ANDA
ORIGINAL APPROVAL
2017-08-07
LATEST ACTION
2025-07-15
ROUTE
TOPICAL, TRANSDERMAL
DOSAGE FORM
SOLUTION, METERED
MARKETING STATUS
Prescription
Products
TESTOSTERONEPrescription
TESTOSTERONE 30MG/1.5ML ACTUATION · SOLUTION, METERED · TRANSDERMAL
Approval history
2025-07-15Labeling · Supplement 6 · standardAP
2019-06-11REMS · Supplement 2AP
2019-05-10Labeling · Supplement 1 · 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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