Last Updated: August 3, 2026

Details for New Drug Application (NDA): 219406

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NDA 219406 describes CLOMIPHENE CITRATE, which is a drug marketed by Accord Hlthcare, Appco, Ascent Pharms Inc, Cosette, Novitium Pharma, and Rubicon Research, and is included in six NDAs. It is available from nine suppliers. Additional details are available on the CLOMIPHENE CITRATE profile page.

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

Summary for 219406

Tradename:	CLOMIPHENE CITRATE
Applicant:	Accord Hlthcare
Ingredient:	clomiphene citrate
Patents:	0

Pharmacology for NDA: 219406

Mechanism of Action	Selective Estrogen Receptor Modulators

Medical Subject Heading (MeSH) Categories for 219406

Estrogen Antagonists
Fertility Agents, Female
Selective Estrogen Receptor Modulators

Suppliers and Packaging for NDA: 219406

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOMIPHENE CITRATE	clomiphene citrate	TABLET;ORAL	219406	ANDA	Accord Healthcare Inc.	16729-723	16729-723-51	1 BLISTER PACK in 1 CARTON (16729-723-51) / 30 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Oct 3, 2025	TE:	AB	RLD:	No

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