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Generated: August 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201546

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NDA 201546 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-two suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.

Summary for NDA: 201546

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

Suppliers and Packaging for NDA: 201546

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride
SYRUP;ORAL 201546 ANDA WALGREEN COMPANY 0363-2106 0363-2106-01 1 BOTTLE in 1 CARTON (0363-2106-01) > 240 mL in 1 BOTTLE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride
SYRUP;ORAL 201546 ANDA WALGREEN COMPANY 0363-2106 0363-2106-08 1 BOTTLE in 1 CARTON (0363-2106-08) > 120 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:May 20, 2011TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:May 20, 2011TE:RLD:No


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