Last Updated: September 24, 2026

Details for New Drug Application (NDA): 083078

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NDA 083078 describes CHLORPHENIRAMINE MALEATE, which is a drug marketed by Aurolife Pharma Llc, Bel Mar, Elkins Sinn, Watson Labs, Pharm Assoc, Avanthi Inc, Anabolic, Bell Pharma, Impax Labs, Ivax Sub Teva Pharms, Kv Pharm, Lederle, Newtron Pharms, Panray, Pharmavite, Pharmeral, Pioneer Pharms, Purepac Pharm, Pvt Form, Roxane, Sun Pharm Industries, Vitarine, and West Ward, and is included in thirty NDAs. It is available from two suppliers. Additional details are available on the CHLORPHENIRAMINE MALEATE profile page.

The generic ingredient in CHLORPHENIRAMINE MALEATE is chlorpheniramine maleate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the chlorpheniramine maleate profile page.

Summary for 083078

Tradename:	CHLORPHENIRAMINE MALEATE
Applicant:	Anabolic
Ingredient:	chlorpheniramine maleate
Patents:	0

Medical Subject Heading (MeSH) Categories for 083078

Anti-Allergic Agents
Antipruritics
Histamine H1 Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	4MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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