APPLICATION
ANDA204570
TYPE
ANDA
ORIGINAL APPROVAL
2019-04-10
LATEST ACTION
2019-11-01
ROUTE
TRANSDERMAL
DOSAGE FORM
GEL, METERED, GEL
MARKETING STATUS
Prescription
Products
TESTOSTERONEPrescription
TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) · GEL, METERED · TRANSDERMAL
TESTOSTERONEPrescription
TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) · GEL · TRANSDERMAL
TESTOSTERONEPrescription
TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) · GEL · TRANSDERMAL
Approval history
2019-11-01Labeling · Supplement 2 · standardAP
2019-05-16Labeling · 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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