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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
QuintilesIMS
Argus Health
Harvard Business School
Chubb
US Department of Justice
Baxter
Queensland Health
AstraZeneca

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090229

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NDA 090229 describes LEVOCETIRIZINE DIHYDROCHLORIDE, which is a drug marketed by Apotex Inc, L Perrigo Co, Silarx Pharms Inc, Taro Pharm Inds, Allied Pharma Inc, Dr Reddys Labs Ltd, Fosun Pharma, Glenmark Generics, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Micro Labs Ltd India, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Sun Pharma Global, Synthon Pharms, and Teva Pharms, and is included in eighteen NDAs. It is available from thirty suppliers. Additional details are available on the LEVOCETIRIZINE DIHYDROCHLORIDE profile page.

The generic ingredient in LEVOCETIRIZINE DIHYDROCHLORIDE is levocetirizine dihydrochloride. There are thirteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
Summary for 090229
Pharmacology for NDA: 090229
Suppliers and Packaging for NDA: 090229
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 090229 ANDA Perrigo New York Inc 45802-594 N 45802-594-65
LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 090229 ANDA Physicians Total Care, Inc. 54868-2077 E 54868-2077-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 26, 2010TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Healthtrust
US Army
Moodys
Johnson and Johnson
AstraZeneca
Chubb
Medtronic
Covington

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