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Generated: November 20, 2018

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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 Actavis Mid Atlantic, Amneal Pharms, Apnar Pharma Lp, Apotex Inc, Aurobindo Pharma, Bio Pharm Inc, Cypress Pharm, Lannett Co Inc, Perrigo R And D, Ranbaxy Labs Ltd, 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 sixty suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 078692
Tradename:CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
Applicant:Sandoz
Ingredient:cetirizine hydrochloride
Patents:0
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 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)
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET, CHEWABLE;ORAL 078692 ANDA Sandoz Inc 0781-5284 0781-5284-64 30 BLISTER PACK in 1 CARTON (0781-5284-64) > 1 TABLET, CHEWABLE in 1 BLISTER PACK (0781-5284-06)

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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