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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 075703

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NDA 075703 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, Pld Acquisitions Llc, and Teva, and is included in eleven NDAs. It is available from three 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. Three suppliers are listed for this compound. Additional details are available on the clemastine fumarate profile page.

Summary for 075703

Tradename:	CLEMASTINE FUMARATE
Applicant:	Apotex Inc
Ingredient:	clemastine fumarate
Patents:	0

Medical Subject Heading (MeSH) Categories for 075703

Anti-Allergic Agents
Antipruritics
Histamine H1 Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYRUP;ORAL			Strength	EQ 0.5MG BASE/5ML
Approval Date:	Nov 27, 2000	TE:		RLD:	No

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