APPLICATION
ANDA086450
TYPE
ANDA
ORIGINAL APPROVAL
1981-02-09
LATEST ACTION
2025-07-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ANDROID 10Discontinued
METHYLTESTOSTERONE 10MG · TABLET · ORAL
Approval history
2025-07-11Labeling · Supplement 15 · standardAP
2016-10-25Labeling · Supplement 14 · standardAP
2015-05-11Labeling · Supplement 13 · standardAP
2014-06-19Labeling · Supplement 12 · standardAP
1996-10-16Manufacturing (CMC) · Supplement 11AP
1996-10-16Labeling · Supplement 8AP
1996-10-16Manufacturing (CMC) · Supplement 6AP
1996-10-16Manufacturing (CMC) · Supplement 10AP
1996-10-16Manufacturing (CMC) · Supplement 9AP
1996-10-16Manufacturing (CMC) · Supplement 7AP
1990-12-18Labeling · Supplement 5AP
1986-06-23Manufacturing (CMC) · Supplement 3AP
1985-06-11Manufacturing (CMC) · Supplement 2AP
1981-02-09OriginalAP
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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