Details for New Drug Application (NDA): 091116

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NDA 091116 describes CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, which is a drug marketed by Amneal Pharms, Apozeal Pharms, Aurobindo Pharma, Bajaj, Chartwell Molecular, Chartwell Rx, Cypress Pharm, Perrigo R And D, Pharm Assoc, Ranbaxy Labs Ltd, Taro, Tris Pharma Inc, Jubilant Generics, and Sun Pharm, and is included in fifteen NDAs. It is available from twenty-seven suppliers. Additional details are available on the CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF profile page.

The generic ingredient in CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and fifty-five suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.

Tradename:	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Applicant:	Jubilant Generics
Ingredient:	cetirizine hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, CHEWABLE;ORAL			Strength	5MG
Approval Date:	Feb 19, 2015	TE:		RLD:	No

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, CHEWABLE;ORAL			Strength	10MG
Approval Date:	Feb 19, 2015	TE:		RLD:	No

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, CHEWABLE;ORAL			Strength	5MG
Approval Date:	Feb 19, 2015	TE:		RLD:	No

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