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Last Updated: March 14, 2026

Details for New Drug Application (NDA): 219032

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NDA 219032 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, 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-nine suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.

Summary for 219032

Tradename:	FEXOFENADINE HYDROCHLORIDE
Applicant:	Contract Pharmacal
Ingredient:	fexofenadine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	60MG
Approval Date:	Feb 28, 2025	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	180MG
Approval Date:	Feb 28, 2025	TE:		RLD:	No

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