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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 078648

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NDA 078648 describes DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE, which is a drug marketed by Avanthi Inc and is included in one NDA. Additional details are available on the DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE profile page.

The generic ingredient in DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE is dexbrompheniramine maleate; pseudoephedrine sulfate. There are seven drug master file entries for this compound. Additional details are available on the dexbrompheniramine maleate; pseudoephedrine sulfate profile page.

Summary for 078648

Tradename:	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE
Applicant:	Avanthi Inc
Ingredient:	dexbrompheniramine maleate; pseudoephedrine sulfate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	6MG;120MG
Approval Date:	Feb 27, 2013	TE:		RLD:	No

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