APPLICATION
ANDA087750
TYPE
ANDA
ORIGINAL APPROVAL
1982-11-24
LATEST ACTION
2025-07-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
VIRILONDiscontinued
METHYLTESTOSTERONE 10MG · CAPSULE · ORAL
Approval history
2025-07-15Labeling · Supplement 17 · standardAP
2017-01-26Labeling · Supplement 16 · standardAP
2015-05-11Labeling · Supplement 15 · standardAP
2014-06-19Labeling · Supplement 14 · standardAP
1993-03-24Labeling · Supplement 8AP
1992-05-07Labeling · Supplement 7AP
1992-03-04Labeling · Supplement 6AP
1989-04-10Labeling · Supplement 5AP
1989-03-06Labeling · Supplement 4AP
1988-07-01Labeling · Supplement 3AP
1982-11-24OriginalAP
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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