APPLICATION
NDA019762
TYPE
NDA
ORIGINAL APPROVAL
1993-10-12
LATEST ACTION
1997-12-17
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
TESTODERMDiscontinued
TESTOSTERONE 4MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
TESTODERMDiscontinued
TESTOSTERONE 6MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
Approval history
1997-12-17Manufacturing (CMC) · Supplement 5 · standardAP
1997-05-12Manufacturing (CMC) · Supplement 4 · standardAP
1996-06-26Manufacturing (CMC) · Supplement 1 · standardAP
1996-05-28Labeling · Supplement 2 · standardAP
1993-10-12Type 3 - New Dosage Form · Original · 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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