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Serving leading biopharmaceutical companies globally:

US Department of Justice
Johnson and Johnson
Chinese Patent Office
Boehringer Ingelheim
Farmers Insurance
Daiichi Sankyo

Generated: January 19, 2018

DrugPatentWatch Database Preview

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 Actavis Mid Atlantic, Allied Pharma Inc, Amneal Pharms, Apotex Inc, Aurobindo Pharma, Bio Pharm Inc, Cypress Pharm, Perrigo R And D, Ranbaxy Labs Ltd, Silarx, Taro, Tris Pharma Inc, Jubilant Generics, Novel Labs Inc, Sandoz, and Sun Pharma Global, and is included in eighteen NDAs. It is available from sixty-three 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 fifty-seven suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 078692
Ingredient:cetirizine hydrochloride
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 078692
Suppliers and Packaging for NDA: 078692
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 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
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 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)

Profile for product number 001

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

Profile for product number 002

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

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Argus Health

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