APPLICATION
ANDA076744
TYPE
ANDA
ORIGINAL APPROVAL
2007-05-23
LATEST ACTION
2024-07-16
ROUTE
TRANSDERMAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription
Products
TESTOSTERONEPrescription
TESTOSTERONE 50MG/5GM PACKET · GEL · TRANSDERMAL
TESTOSTERONEPrescription
TESTOSTERONE 25MG/2.5GM PACKET · GEL · TRANSDERMAL
Approval history
2024-07-16Labeling · Supplement 18 · standardAP
2019-06-03Labeling · Supplement 9 · standardAP
2019-06-03Labeling · Supplement 10 · standardAP
2019-06-03Labeling · Supplement 8 · standardAP
2015-09-25REMS · Supplement 5AP
2015-06-30Labeling · Supplement 3AP
2015-06-30Labeling · Supplement 6 · standardAP
2015-06-30Labeling · Supplement 4 · standardAP
2009-01-06Labeling · Supplement 1AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.