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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 086987

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NDA 086987 describes BROMPHENIRAMINE MALEATE, which is a drug marketed by Alpharma Us Pharms, Kv Pharm, Pharm Assoc, Usl Pharma, Watson Labs, Barr, Ivax Sub Teva Pharms, Newtron Pharms, Nexgen Pharma Inc, Par Pharm, Pioneer Pharms, Upsher Smith Labs, Vitarine, Acella, Alkem Labs Ltd, Bionpharma, Chartwell Molecular, Dr Reddys Labs Sa, Padagis Us, Rhodes Pharms, Taro, and Wes Pharma Inc, and is included in twenty-six NDAs. Additional details are available on the BROMPHENIRAMINE MALEATE profile page.

The generic ingredient in BROMPHENIRAMINE MALEATE is brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride. There are twenty-one drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride profile page.

Summary for 086987

Tradename:	BROMPHENIRAMINE MALEATE
Applicant:	Newtron Pharms
Ingredient:	brompheniramine maleate
Patents:	0

Medical Subject Heading (MeSH) Categories for 086987

Anti-Allergic Agents
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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