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Serving leading biopharmaceutical companies globally:

QuintilesIMS
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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090750

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NDA 090750 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-nine 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 fifty-nine suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.

Summary for 090750

Tradename:2
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 090750

Suppliers and Packaging for NDA: 090750

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride SYRUP;ORAL 090750 ANDA Fred's, Inc. 55315-354 55315-354-31 1 BOTTLE in 1 CARTON (55315-354-31) > 120 mL in 1 BOTTLE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride SYRUP;ORAL 090750 ANDA Aurohealth LLC 58602-028 58602-028-26 480 mL in 1 BOTTLE (58602-028-26)

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Feb 2, 2010TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Feb 2, 2010TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Julphar
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