APPLICATION
ANDA084310
TYPE
ANDA
ORIGINAL APPROVAL
1974-06-21
LATEST ACTION
2015-05-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHYLTESTOSTERONEDiscontinued
METHYLTESTOSTERONE 25MG · TABLET · ORAL
Approval history
2015-05-11Labeling · Supplement 78 · standardAP
2014-06-19Labeling · Supplement 77 · standardAP
2002-11-04Labeling · Supplement 76AP
2002-05-07Manufacturing (CMC) · Supplement 74AP
2002-05-07Labeling · Supplement 75AP
2000-03-10Labeling · Supplement 72AP
1999-08-13Manufacturing (CMC) · Supplement 73AP
1997-10-29Labeling · Supplement 71AP
1991-10-09Labeling · Supplement 70AP
1991-07-05Labeling · Supplement 68AP
1991-07-05Labeling · Supplement 69AP
1990-01-19Labeling · Supplement 67AP
1989-10-23Labeling · Supplement 65AP
1989-06-22Labeling · Supplement 64AP
1988-10-31Labeling · Supplement 63AP
1988-07-06Labeling · Supplement 62AP
1974-06-21OriginalAP
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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