Last Updated: September 24, 2026

Details for New Drug Application (NDA): 077081

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NDA 077081 describes FEXOFENADINE HYDROCHLORIDE HIVES, which is a drug marketed by Dr Reddys Labs Ltd, Rising, Sciegen Pharms, Sun Pharm Inds, Teva, and Time Cap Labs, and is included in six NDAs. It is available from forty-two suppliers. Additional details are available on the FEXOFENADINE HYDROCHLORIDE HIVES profile page.

The generic ingredient in FEXOFENADINE HYDROCHLORIDE HIVES is fexofenadine hydrochloride. There is one drug master file entry for this compound. One hundred and five suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.

Summary for 077081

Tradename:	FEXOFENADINE HYDROCHLORIDE HIVES
Applicant:	Rising
Ingredient:	fexofenadine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	180MG
Approval Date:	Apr 16, 2007	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	Apr 11, 2008	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	60MG
Approval Date:	Apr 11, 2008	TE:		RLD:	No

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