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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 073399

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NDA 073399 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 073399

Tradename:	CLEMASTINE FUMARATE
Applicant:	Genus
Ingredient:	clemastine fumarate
Patents:	0

Medical Subject Heading (MeSH) Categories for 073399

Anti-Allergic Agents
Antipruritics
Histamine H1 Antagonists

Suppliers and Packaging for NDA: 073399

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLEMASTINE FUMARATE	clemastine fumarate	SYRUP;ORAL	073399	ANDA	Genus Lifesciences	64950-324	64950-324-12	120 mL in 1 BOTTLE (64950-324-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	EQ 0.5MG BASE/5ML
Approval Date:	Jun 30, 1994	TE:	AA	RLD:	No

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