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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 007638

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NDA 007638 describes CHLOR-TRIMETON, which is a drug marketed by Schering Plough, Schering, and Bayer Healthcare Llc, and is included in five NDAs. Additional details are available on the CHLOR-TRIMETON profile page.

The generic ingredient in CHLOR-TRIMETON is chlorpheniramine maleate; pseudoephedrine sulfate. There are twenty-nine drug master file entries for this compound. Additional details are available on the chlorpheniramine maleate; pseudoephedrine sulfate profile page.

Summary for 007638

Tradename:	CHLOR-TRIMETON
Applicant:	Bayer Healthcare Llc
Ingredient:	chlorpheniramine maleate
Patents:	0

Medical Subject Heading (MeSH) Categories for 007638

Anti-Allergic Agents
Antipruritics
Histamine H1 Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

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