APPLICATION
ANDA072196
TYPE
ANDA
ORIGINAL APPROVAL
1988-12-20
LATEST ACTION
2025-08-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MILOPHENEPrescription
CLOMIPHENE CITRATE 50MG · TABLET · ORAL
Approval history
2025-08-15Manufacturing (CMC) · Supplement 8 · unknownAP
1998-01-23Manufacturing (CMC) · Supplement 1AP
1998-01-23Manufacturing (CMC) · Supplement 4AP
1998-01-23Manufacturing (CMC) · Supplement 2AP
1998-01-23Manufacturing (CMC) · Supplement 5AP
1998-01-23Labeling · Supplement 3AP
1988-12-20OriginalAP
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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