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FDA ANDA · ANDA088342

FLUOXYMESTERONE

Sponsor: UPSHER SMITH LABS

APPLICATION
ANDA088342
TYPE
ANDA
ORIGINAL APPROVAL
1983-10-21
LATEST ACTION
1992-04-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

FLUOXYMESTERONEDiscontinued
FLUOXYMESTERONE 10MG · TABLET · ORAL

Approval history

1992-04-06Labeling · Supplement 25AP
1991-12-11Labeling · Supplement 24AP
1991-07-02Labeling · Supplement 22AP
1990-03-08Labeling · Supplement 21AP
1989-11-07Labeling · Supplement 20AP
1989-01-12Labeling · Supplement 19AP
1988-05-26Manufacturing (CMC) · Supplement 17AP
1987-12-26Manufacturing (CMC) · Supplement 18AP
1986-09-17Manufacturing (CMC) · Supplement 13AP
1986-09-17Manufacturing (CMC) · Supplement 14AP
1986-09-17Manufacturing (CMC) · Supplement 12AP
1986-08-27Manufacturing (CMC) · Supplement 9AP
1986-03-20Manufacturing (CMC) · Supplement 10AP
1984-07-17Manufacturing (CMC) · Supplement 3AP
1984-07-17Manufacturing (CMC) · Supplement 1AP
1984-07-17Manufacturing (CMC) · Supplement 4AP
1984-07-17Manufacturing (CMC) · Supplement 2AP
1983-10-21OriginalAP
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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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