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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 088682

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NDA 088682 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 088682

Tradename:	DEXCHLORPHENIRAMINE MALEATE
Applicant:	Ani Pharms
Ingredient:	dexchlorpheniramine maleate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Jan 17, 1986	TE:		RLD:	No

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