APPLICATION
ANDA080281
TYPE
ANDA
ORIGINAL APPROVAL
1979-08-03
LATEST ACTION
1994-01-19
ROUTE
BUCCAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ORETONDiscontinued
METHYLTESTOSTERONE 10MG · TABLET · BUCCAL
Approval history
1994-01-19Labeling · Supplement 9AP
1991-06-27Labeling · Supplement 7AP
1991-06-27Labeling · Supplement 8AP
1979-08-03OriginalAP
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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