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Generated: December 10, 2018

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Details for New Drug Application (NDA): 090191

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NDA 090191 describes CETIRIZINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Amneal Pharms, Anda Repository, Apotex Inc, Aurobindo Pharma Ltd, Bio Pharm Inc, Breckenridge Pharm, Lannett Co Inc, Perrigo R And D, Ranbaxy Labs Ltd, Taro, Teva Pharms, Wockhardt, Bionpharma Inc, Strides Pharma, Sun Pharm Inds Inc, 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, Torrent Pharms Llc, Unichem, Unique Pharm Labs, and Ivax Sub Teva Pharms, and is included in forty-four NDAs. It is available from fourteen suppliers. Additional details are available on the CETIRIZINE HYDROCHLORIDE profile page.

The generic ingredient in CETIRIZINE HYDROCHLORIDE is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.
Summary for 090191
Tradename:CETIRIZINE HYDROCHLORIDE
Applicant:Anda Repository
Ingredient:cetirizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090191
Medical Subject Heading (MeSH) Categories for 090191
Suppliers and Packaging for NDA: 090191
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE cetirizine hydrochloride SYRUP;ORAL 090191 ANDA Caraco Pharmaceutical Laboratories, Ltd. 57664-181 57664-181-31 120 mL in 1 BOTTLE, GLASS (57664-181-31)
CETIRIZINE HYDROCHLORIDE cetirizine hydrochloride SYRUP;ORAL 090191 ANDA Caraco Pharmaceutical Laboratories, Ltd. 57664-181 57664-181-34 473 mL in 1 BOTTLE, GLASS (57664-181-34)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Nov 12, 2009TE:AARLD:No

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