Last Updated: September 24, 2026

Details for New Drug Application (NDA): 220673

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NDA 220673 describes CLOMIPHENE CITRATE, which is a drug marketed by Accord Hlthcare, Appco, Ascent Pharms Inc, Novitium Pharma, and Rubicon Research, and is included in five NDAs. It is available from seven suppliers. Additional details are available on the CLOMIPHENE CITRATE profile page.

The generic ingredient in CLOMIPHENE CITRATE is clomiphene citrate. There is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the clomiphene citrate profile page.

Summary for 220673

Tradename:	CLOMIPHENE CITRATE
Applicant:	Ascent Pharms Inc
Ingredient:	clomiphene citrate
Patents:	0

Pharmacology for NDA: 220673

Mechanism of Action	Selective Estrogen Receptor Modulators

Medical Subject Heading (MeSH) Categories for 220673

Estrogen Antagonists
Fertility Agents, Female
Selective Estrogen Receptor Modulators

Suppliers and Packaging for NDA: 220673

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOMIPHENE CITRATE	clomiphene citrate	TABLET;ORAL	220673	ANDA	Camber Pharmaceuticals Inc	31722-541	31722-541-32	1 BLISTER PACK in 1 CARTON (31722-541-32) / 10 TABLET in 1 BLISTER PACK
CLOMIPHENE CITRATE	clomiphene citrate	TABLET;ORAL	220673	ANDA	Camber Pharmaceuticals Inc	31722-541	31722-541-33	3 BLISTER PACK in 1 CARTON (31722-541-33) / 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	May 15, 2026	TE:	AB	RLD:	No

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