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Generated: May 26, 2017

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Details for New Drug Application (NDA): 078692

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NDA 078692 describes CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Cypress Pharm, Jubilant Generics, Perrigo R And D, Allied Pharma Inc, Silarx, Sun Pharma Global, Taro, Aurobindo Pharma, Amneal Pharms, Tris Pharma Inc, Bio Pharm Inc, Actavis Mid Atlantic, Ranbaxy Labs Ltd, Apotex Inc, Sandoz, and Novel Labs Inc, and is included in eighteen NDAs. It is available from sixty-eight suppliers. Additional details are available on the CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY profile page.

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

Summary for NDA: 078692

Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 078692

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
cetirizine hydrochloride
TABLET, CHEWABLE;ORAL 078692 ANDA Walgreen Company 0363-5780 0363-5780-22 2 BLISTER PACK in 1 CARTON (0363-5780-22) > 6 TABLET, CHEWABLE in 1 BLISTER PACK
cetirizine hydrochloride
TABLET, CHEWABLE;ORAL 078692 ANDA Sandoz Inc 0781-5283 0781-5283-64 30 BLISTER PACK in 1 CARTON (0781-5283-64) > 1 TABLET, CHEWABLE in 1 BLISTER PACK (0781-5283-06)

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, CHEWABLE;ORALStrength5MG
Approval Date:Feb 14, 2008TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, CHEWABLE;ORALStrength10MG
Approval Date:Feb 14, 2008TE:RLD:No

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