Last Updated: September 27, 2026

Details for New Drug Application (NDA): 020497

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NDA 020497 describes FARESTON, which is a drug marketed by Kyowa Kirin and is included in one NDA. It is available from one supplier. Additional details are available on the FARESTON profile page.

The generic ingredient in FARESTON is toremifene citrate. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the toremifene citrate profile page.

Summary for 020497

Tradename:	FARESTON
Applicant:	Kyowa Kirin
Ingredient:	toremifene citrate
Patents:	0

Pharmacology for NDA: 020497

Mechanism of Action	Selective Estrogen Receptor Modulators

Medical Subject Heading (MeSH) Categories for 020497

Antineoplastic Agents, Hormonal
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators

Suppliers and Packaging for NDA: 020497

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FARESTON	toremifene citrate	TABLET;ORAL	020497	NDA	Kyowa Kirin, Inc.	42747-327	42747-327-30	30 TABLET in 1 BOTTLE (42747-327-30)
FARESTON	toremifene citrate	TABLET;ORAL	020497	NDA	Kyowa Kirin, Inc.	42747-327	42747-327-72	7 TABLET in 1 BLISTER PACK (42747-327-72)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 60MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 29, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020497

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kyowa Kirin	FARESTON	toremifene citrate	TABLET;ORAL	020497-001	May 29, 1997	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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