APPLICATION
ANDA087092
TYPE
ANDA
ORIGINAL APPROVAL
1982-11-05
LATEST ACTION
2025-07-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHYLTESTOSTERONEDiscontinued
METHYLTESTOSTERONE 10MG · TABLET · ORAL
Approval history
2025-07-11Labeling · Supplement 7 · standardAP
2016-10-25Labeling · Supplement 5 · standardAP
2015-05-11Labeling · Supplement 4 · standardAP
2014-06-19Labeling · Supplement 3 · standardAP
1988-01-05Labeling · Supplement 1AP
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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