APPLICATION
ANDA075528
TYPE
ANDA
ORIGINAL APPROVAL
1999-08-30
LATEST ACTION
2026-02-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CLOMIPHENE CITRATEPrescription
CLOMIPHENE CITRATE 50MG · TABLET · ORAL
Approval history
2026-02-24Labeling · Supplement 28 · standardAP
2025-12-18Labeling · Supplement 18 · standardAP
2013-05-23Labeling · Supplement 9 · standardAP
2013-02-19Labeling · Supplement 8 · standardAP
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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