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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Moodys
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Cerilliant
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Cantor Fitzgerald
Healthtrust
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Generated: October 19, 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 Actavis Elizabeth, Apotex Inc, Cipla Ltd, Wockhardt, Bionpharma Inc, Unique Pharm Labs, Sun Pharm Inds Inc, Jubilant Cadista, Perrigo R And D, Dr Reddys Labs Ltd, Sandoz, Contract Pharmacal, Aurobindo Pharma Ltd, Orchid Hlthcare, Taro, Ipca Labs Ltd, Mylan, Amneal Pharms Ny, Unichem, Strides Pharma, Torrent Pharms Llc, and Sun Pharm Inds Ltd, and is included in twenty-five NDAs. It is available from one hundred and thirty 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 sixty-two suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.

Summary for NDA: 077318

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

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 49035-312-05 1 BOTTLE in 1 CARTON (49035-312-05) > 90 TABLET, FILM COATED in 1 BOTTLE
CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride
TABLET;ORAL 077318 ANDA Wal-Mart Stores, Inc. 49035-312 49035-312-56 1 BLISTER PACK in 1 CARTON (49035-312-56) > 14 TABLET, FILM COATED in 1 BLISTER PACK

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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Serving leading biopharmaceutical companies globally:

McKesson
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Chinese Patent Office
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Harvard Business School
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