APPLICATION
ANDA080767
TYPE
ANDA
ORIGINAL APPROVAL
1974-10-17
LATEST ACTION
2025-07-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METHYLTESTOSTERONEPrescription
METHYLTESTOSTERONE 10MG · TABLET · ORAL
Approval history
2025-07-11Labeling · Supplement 91 · standardAP
2016-10-25Labeling · Supplement 82 · standardAP
2015-05-11Labeling · Supplement 78 · standardAP
2014-06-19Labeling · Supplement 77 · standardAP
2002-11-04Labeling · Supplement 67AP
2002-03-08Manufacturing (CMC) · Supplement 65AP
2002-03-08Labeling · Supplement 66AP
2000-03-10Labeling · Supplement 64AP
1997-10-29Labeling · Supplement 63AP
1991-10-09Labeling · Supplement 62AP
1991-07-05Labeling · Supplement 61AP
1990-01-19Labeling · Supplement 60AP
1989-07-20Labeling · Supplement 59AP
1989-07-20Labeling · Supplement 58AP
1988-10-31Labeling · Supplement 57AP
1988-07-06Labeling · Supplement 55AP
1974-10-17OriginalAP
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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