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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 215574

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NDA 215574 describes OSPEMIFENE, which is a drug marketed by Hetero Labs Ltd V and is included in one NDA. Additional details are available on the OSPEMIFENE profile page.

The generic ingredient in OSPEMIFENE is ospemifene. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ospemifene profile page.

Summary for 215574

Tradename:	OSPEMIFENE
Applicant:	Hetero Labs Ltd V
Ingredient:	ospemifene
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	60MG
Approval Date:	Feb 13, 2024	TE:		RLD:	No

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