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Serving 500+ biopharmaceutical companies globally:

Generated: September 20, 2017

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Details for New Drug Application (NDA): 077829

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NDA 077829 describes CETIRIZINE HYDROCHLORIDE HIVES, which is a drug marketed by Unique Pharm Labs, Jubilant Cadista, Perrigo R And D, Dr Reddys Labs Ltd, Orchid Hlthcare, Ipca Labs Ltd, Mylan, Unichem, Sun Pharm Inds Ltd, Sun Pharm Inds Inc, Bionpharma Inc, Aurobindo Pharma Ltd, Taro, Amneal Pharms Ny, and Torrent Pharms Llc, and is included in sixteen NDAs. It is available from eighty-seven suppliers. Additional details are available on the CETIRIZINE HYDROCHLORIDE HIVES profile page.

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

Summary for NDA: 077829

Tradename:	2
Applicant:	1
Ingredient:	1
Patents:	0
Therapeutic Class:	Respiratory Tract Agents
Formulation / Manufacturing:	see details

Pharmacology for NDA: 077829

Mechanism of Action	Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 077829

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CETIRIZINE HYDROCHLORIDE ALLERGY	cetirizine hydrochloride	TABLET;ORAL	077829	ANDA	Kaiser Foundation Hospitals	0179-8301	0179-8301-01	100 TABLET in 1 BOTTLE (0179-8301-01)
CETIRIZINE HYDROCHLORIDE ALLERGY	cetirizine hydrochloride	TABLET;ORAL	077829	ANDA	Kaiser Foundation Hospitals	0179-8302	0179-8302-01	100 TABLET in 1 BOTTLE (0179-8302-01)

Summary for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Aug 26, 2009	TE:		RLD:	No

Summary for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Aug 26, 2009	TE:		RLD:	No

Summary for product number 003

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Aug 26, 2009	TE:		RLD:	No

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