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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 202978

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NDA 202978 describes CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, which is a drug marketed by P And L, Taro, Dr Reddys Labs Ltd, Rising, Sun Pharm Inds, Teva, and Wockhardt, and is included in eight NDAs. It is available from thirty-three suppliers. Additional details are available on the CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES profile page.

The generic ingredient in CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES is fexofenadine hydrochloride. There are twenty-three drug master file entries for this compound. One hundred and four suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.

Summary for 202978

Tradename:	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
Applicant:	Dr Reddys Labs Ltd
Ingredient:	fexofenadine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	30MG
Approval Date:	Jan 18, 2013	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	30MG
Approval Date:	Jan 18, 2013	TE:		RLD:	No

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