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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 076169

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NDA 076169 describes FEXOFENADINE HYDROCHLORIDE, which is a drug marketed by Barr, Aurobindo Pharma Ltd, P And L, Contract Pharmacal, Dr Reddys Labs Ltd, L Perrigo Co, Rising, Teva, Granules, Hetero Labs Ltd V, Sciegen Pharms Inc, Sun Pharm Inds, Unique, Wockhardt, Aurobindo Pharma, Dr Reddys, Impax Pharms, and Sun Pharm, and is included in twenty-five NDAs. It is available from thirty-seven suppliers. Additional details are available on the FEXOFENADINE HYDROCHLORIDE profile page.

The generic ingredient in FEXOFENADINE 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 076169

Tradename:	FEXOFENADINE HYDROCHLORIDE
Applicant:	Barr
Ingredient:	fexofenadine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	60MG
Approval Date:	Jul 13, 2005	TE:		RLD:	No

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