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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 018675

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NDA 018675 describes TAVIST, which is a drug marketed by Novartis and Haleon Us Holdings and is included in four NDAs. Additional details are available on the TAVIST profile page.

The generic ingredient in TAVIST is acetaminophen; clemastine fumarate; pseudoephedrine hydrochloride. There are sixty-six drug master file entries for this compound. Additional details are available on the acetaminophen; clemastine fumarate; pseudoephedrine hydrochloride profile page.

Summary for 018675

Tradename:	TAVIST
Applicant:	Novartis
Ingredient:	clemastine fumarate
Patents:	0

Medical Subject Heading (MeSH) Categories for 018675

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Dosage:	SYRUP;ORAL			Strength	EQ 0.5MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 28, 1985	TE:		RLD:	Yes

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