APPLICATION
ANDA076737
TYPE
ANDA
ORIGINAL APPROVAL
2006-01-27
LATEST ACTION
2019-06-03
ROUTE
TOPICAL, TRANSDERMAL
DOSAGE FORM
GEL, GEL, METERED
MARKETING STATUS
Prescription
Products
TESTOSTERONEPrescription
TESTOSTERONE 50MG/5GM PACKET · GEL · TRANSDERMAL
TESTOSTERONEPrescription
TESTOSTERONE 12.5MG/1.25GM ACTUATION · GEL, METERED · TRANSDERMAL
TESTOSTERONEPrescription
TESTOSTERONE 25MG/2.5GM PACKET · GEL · TRANSDERMAL
Approval history
2019-06-03Labeling · Supplement 13 · standardAP
2019-06-03Labeling · Supplement 9 · standardAP
2015-11-05REMS · Supplement 6AP
2015-10-28Labeling · Supplement 7 · 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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