BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Argus Health
AstraZeneca
Fuji
QuintilesIMS
Harvard Business School
Express Scripts
Daiichi Sankyo
US Army
Medtronic

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090385

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NDA 090385 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, Glenmark Generics, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Sandoz, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Sun Pharma Global, Synthon Pharms, and Teva Pharms, and is included in seventeen NDAs. It is available from twenty-six 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 suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
Summary for 090385
Pharmacology for NDA: 090385
Suppliers and Packaging for NDA: 090385
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 090385 ANDA Bryant Ranch Prepack 63629-4492 63629-4492-1 30 TABLET in 1 BOTTLE (63629-4492-1)
LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 090385 ANDA Bryant Ranch Prepack 63629-4492 63629-4492-3 28 TABLET in 1 BOTTLE (63629-4492-3)

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Novartis
Fuji
Chinese Patent Office
Chubb
Moodys
Healthtrust
Deloitte
Queensland Health

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