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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 088251

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NDA 088251 describes DEXCHLORPHENIRAMINE MALEATE, which is a drug marketed by Pai Holdings Pharm and Ani Pharms and is included in two NDAs. Additional details are available on the DEXCHLORPHENIRAMINE MALEATE profile page.

The generic ingredient in DEXCHLORPHENIRAMINE MALEATE is dexchlorpheniramine maleate. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dexchlorpheniramine maleate profile page.

Summary for 088251

Tradename:	DEXCHLORPHENIRAMINE MALEATE
Applicant:	Pai Holdings Pharm
Ingredient:	dexchlorpheniramine maleate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYRUP;ORAL			Strength	2MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 23, 1984	TE:		RLD:	Yes

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