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Generated: April 23, 2018

DrugPatentWatch Database Preview

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 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, and Sun Pharma Global, and is included in fifteen NDAs. It is available from forty-two 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 forty-two suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 091116
Tradename:CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Applicant:Jubilant Generics
Ingredient:cetirizine hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 091116
Suppliers and Packaging for NDA: 091116
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET, CHEWABLE;ORAL 091116 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-285 N 59746-285-32
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET, CHEWABLE;ORAL 091116 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-285 N 59746-285-33

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, CHEWABLE;ORALStrength5MG
Approval Date:Feb 19, 2015TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, CHEWABLE;ORALStrength10MG
Approval Date:Feb 19, 2015TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:OTCDosage:TABLET, CHEWABLE;ORALStrength5MG
Approval Date:Feb 19, 2015TE:RLD:No

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