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Generated: January 24, 2019

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Details for New Drug Application (NDA): 207235

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NDA 207235 describes CETIRIZINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Bionpharma Inc, Strides Pharma, Sun Pharm Inds Inc, Perrigo R And D, Actavis Elizabeth, Amneal Pharms Ny, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Granules India Ltd, Ipca Labs Ltd, Marksans Pharma, Mylan, Orchid Hlthcare, Pld Acquisitions, Sun Pharm Inds Ltd, Taro, Torrent Pharms Llc, Unichem, Unique Pharm Labs, and Wockhardt, and is included in twenty-seven NDAs. It is available from one hundred and thirty-one 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-one suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 207235
Tradename:CETIRIZINE HYDROCHLORIDE ALLERGY
Applicant:Apotex Inc
Ingredient:cetirizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 207235
Suppliers and Packaging for NDA: 207235
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride CAPSULE;ORAL 207235 ANDA Walgreens 0363-1040 0363-1040-02 1 BOTTLE in 1 CARTON (0363-1040-02) > 25 CAPSULE, LIQUID FILLED in 1 BOTTLE
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride CAPSULE;ORAL 207235 ANDA Walgreens 0363-1040 0363-1040-04 1 BOTTLE in 1 BLISTER PACK (0363-1040-04) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE;ORALStrength10MG
Approval Date:Aug 12, 2016TE:RLD:No

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