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Generated: July 21, 2017

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 Cypress Pharm, Jubilant Generics, Allied Pharma Inc, Silarx, Sun Pharma Global, Taro, Aurobindo Pharma, Perrigo R And D, Amneal Pharms, Tris Pharma Inc, Bio Pharm Inc, Actavis Mid Atlantic, Ranbaxy Labs Ltd, and Apotex Inc, and is included in fifteen NDAs. It is available from sixty 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 sixty suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.

Summary for NDA: 091116

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

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 59746-285-32 3 BLISTER PACK in 1 CARTON (59746-285-32) > 30 TABLET, CHEWABLE in 1 BLISTER PACK
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride
TABLET, CHEWABLE;ORAL 091116 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-285 59746-285-33 3 BLISTER PACK in 1 CARTON (59746-285-33) > 10 TABLET, CHEWABLE in 1 BLISTER PACK

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving 500+ biopharmaceutical companies globally:

Fuji
Chinese Patent Office
McKinsey
Boehringer Ingelheim
Chubb
Cantor Fitzgerald
Accenture
McKesson
Healthtrust
Harvard Business School

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