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Serving leading biopharmaceutical companies globally:

Baxter
Dow
Boehringer Ingelheim
Cantor Fitzgerald
Argus Health
US Army
Teva
US Department of Justice
AstraZeneca
Citi

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076601

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NDA 076601 describes CETIRIZINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Allied Pharma Inc, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Bio Pharm Inc, Breckenridge Pharm, Perrigo R And D, Ranbaxy Labs Ltd, Silarx, Taro, Teva Pharms, Vintage, Wockhardt, Bionpharma Inc, Strides Pharma, Sun Pharm Inds Inc, Actavis Elizabeth, Amneal Pharms Ny, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Ipca Labs Ltd, Jubilant Cadista, Mylan, Orchid Hlthcare, Sandoz, Sun Pharm Inds Ltd, Torrent Pharms Llc, Unichem, Unique Pharm Labs, and Ivax Sub Teva Pharms, and is included in forty-two NDAs. It is available from thirteen 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-three suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.
Summary for 076601
Tradename:CETIRIZINE HYDROCHLORIDE
Applicant:Taro
Ingredient:cetirizine hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076601
Medical Subject Heading (MeSH) Categories for 076601
Suppliers and Packaging for NDA: 076601
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE cetirizine hydrochloride SYRUP;ORAL 076601 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4070 51672-4070-8 1 BOTTLE in 1 CARTON (51672-4070-8) > 120 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Jun 20, 2008TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Teva
Federal Trade Commission
Fuji
Colorcon
Queensland Health
Julphar
Harvard Business School
Medtronic
Chubb

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