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Farmers Insurance
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US Department of Justice
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Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090392

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NDA 090392 describes LEVOCETIRIZINE DIHYDROCHLORIDE, which is a drug marketed by Apotex Inc, L Perrigo Co, Lannett Co Inc, Taro Pharm Inds Ltd, 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-one 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-five suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
Summary for 090392
Pharmacology for NDA: 090392
Suppliers and Packaging for NDA: 090392
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 090392 ANDA Dr.Reddy's laboratories Ltd. 55111-282 N 55111-282-01
LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 090392 ANDA Dr.Reddy's laboratories Ltd. 55111-282 N 55111-282-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 24, 2011TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
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Daiichi Sankyo
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US Army
Argus Health
Fish and Richardson
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