APPLICATION
NDA018361
TYPE
NDA
ORIGINAL APPROVAL
1982-03-22
LATEST ACTION
2003-07-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SEROPHENEDiscontinued
CLOMIPHENE CITRATE 50MG · TABLET · ORAL
Approval history
2003-07-31Labeling · Supplement 29AP
2002-08-13Labeling · Supplement 28AP
2001-08-14Labeling · Supplement 27AP
2001-02-01Manufacturing (CMC) · Supplement 26AP
1996-04-02Labeling · Supplement 24AP
1994-12-30Manufacturing (CMC) · Supplement 22AP
1985-08-21Manufacturing (CMC) · Supplement 1AP
1982-03-22OriginalAP
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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