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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 216792

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NDA 216792 describes FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Barr, Dr Reddys, Dr Reddys Labs Ltd, Impax Pharms, L Perrigo Co, and Sun Pharm, and is included in nine NDAs. It is available from twenty-five suppliers. Additional details are available on the FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE profile page.

The generic ingredient in FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.

Summary for 216792

Tradename:	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Applicant:	L Perrigo Co
Ingredient:	fexofenadine hydrochloride; pseudoephedrine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	60MG;120MG
Approval Date:	Oct 7, 2025	TE:		RLD:	No

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