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FDA ANDA · ANDA084287

METHYLTESTOSTERONE

Sponsor: IMPAX LABS

APPLICATION
ANDA084287
TYPE
ANDA
ORIGINAL APPROVAL
1974-07-16
LATEST ACTION
1997-10-29
ROUTE
BUCCAL, SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

METHYLTESTOSTERONEDiscontinued
METHYLTESTOSTERONE 10MG · TABLET · BUCCAL, SUBLINGUAL

Approval history

1997-10-29Labeling · Supplement 66AP
1991-10-09Labeling · Supplement 65AP
1991-07-05Labeling · Supplement 64AP
1990-01-19Labeling · Supplement 63AP
1989-11-28Labeling · Supplement 62AP
1989-07-20Labeling · Supplement 61AP
1989-05-11Labeling · Supplement 60AP
1988-10-31Labeling · Supplement 59AP
1988-07-06Labeling · Supplement 58AP
1974-07-16OriginalAP
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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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