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Serving leading biopharmaceutical companies globally:

AstraZeneca
Farmers Insurance
Covington
Accenture
QuintilesIMS
Healthtrust
Fuji
Cipla
McKesson
Merck

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203027

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NDA 203027 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-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 203027

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Respiratory Tract Agents

Pharmacology for NDA: 203027

Suppliers and Packaging for NDA: 203027

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 203027 ANDA Apotex Corp. 60505-3713 60505-3713-9 90 TABLET in 1 BOTTLE (60505-3713-9)
LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 203027 ANDA Apotex Corp. 60505-3713 60505-3713-5 500 TABLET in 1 BOTTLE (60505-3713-5)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 13, 2015TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

McKinsey
Novartis
Cipla
US Army
Daiichi Sankyo
Chinese Patent Office
Healthtrust
Mallinckrodt
Queensland Health
Teva

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