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Serving leading biopharmaceutical companies globally:

Healthtrust
Fish and Richardson
Boehringer Ingelheim
Cantor Fitzgerald
Fuji
Cerilliant
QuintilesIMS
Queensland Health
US Army
Federal Trade Commission

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091264

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NDA 091264 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 twenty-seven 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-one suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
Summary for 091264
Pharmacology for NDA: 091264
Suppliers and Packaging for NDA: 091264
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 091264 ANDA Camber Pharmaceuticals, Inc. 31722-551 N 31722-551-90
LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 091264 ANDA Camber Pharmaceuticals, Inc. 31722-551 N 31722-551-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 29, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
QuintilesIMS
Teva
Cerilliant
Boehringer Ingelheim
Accenture
Mallinckrodt
Colorcon
Chubb

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