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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 074512

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NDA 074512 describes CLEMASTINE FUMARATE, which is a drug marketed by Actavis Mid Atlantic, Apotex Inc, Genus, New Heightsrx, Teva Pharms, Wockhardt Bio Ag, Ani Pharms, L Perrigo Co, Omnivium Pharms, and Pld Acquisitions Llc, and is included in eleven NDAs. It is available from four suppliers. Additional details are available on the CLEMASTINE FUMARATE profile page.

The generic ingredient in CLEMASTINE FUMARATE is clemastine fumarate. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the clemastine fumarate profile page.

Summary for 074512

Tradename:	CLEMASTINE FUMARATE
Applicant:	L Perrigo Co
Ingredient:	clemastine fumarate
Patents:	0

Medical Subject Heading (MeSH) Categories for 074512

Anti-Allergic Agents
Antipruritics
Histamine H1 Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1.34MG
Approval Date:	Nov 22, 1995	TE:		RLD:	No

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