APPLICATION
ANDA208061
TYPE
ANDA
ORIGINAL APPROVAL
2017-10-23
LATEST ACTION
2025-07-11
ROUTE
TOPICAL, TRANSDERMAL
DOSAGE FORM
SOLUTION, METERED
MARKETING STATUS
Prescription
Products
TESTOSTERONEPrescription
TESTOSTERONE 30MG/1.5ML ACTUATION · SOLUTION, METERED · TRANSDERMAL
Approval history
2025-07-11Labeling · Supplement 13 · standardAP
2020-01-29Manufacturing (CMC) · Supplement 4AP
2019-06-04REMS · 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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