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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077318

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NDA 077318 describes CETIRIZINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Apotex Inc, Bionpharma Inc, Strides Pharma, Sun Pharm Inds Inc, Perrigo R And D, Actavis Elizabeth, Amneal Pharms Ny, Aurobindo Pharma Ltd, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Ipca Labs Ltd, Jubilant Cadista, Mylan, Orchid Hlthcare, Sandoz, Sun Pharm Inds Ltd, Taro, Torrent Pharms Llc, Unichem, Unique Pharm Labs, and Wockhardt, and is included in twenty-five NDAs. It is available from one hundred and twenty-six suppliers. Additional details are available on the CETIRIZINE HYDROCHLORIDE ALLERGY profile page.

The generic ingredient in CETIRIZINE HYDROCHLORIDE ALLERGY 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 077318

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

Medical Subject Heading (MeSH) Categories for 077318

Suppliers and Packaging for NDA: 077318

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 077318 ANDA Wal-Mart Stores, Inc. 49035-312 49035-312-58 2 BOTTLE in 1 CARTON (49035-312-58) > 90 TABLET, FILM COATED in 1 BOTTLE
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 077318 ANDA Wal-Mart Stores, Inc. 49035-312 49035-312-05 1 BOTTLE in 1 CARTON (49035-312-05) > 90 TABLET, FILM COATED in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength5MG
Approval Date:Jul 25, 2013TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Jul 25, 2013TE:RLD:No


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