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Serving leading biopharmaceutical companies globally:

Baxter
Boehringer Ingelheim
Chubb
Argus Health
AstraZeneca
Novartis
Deloitte
Farmers Insurance
Julphar
Citi

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090199

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NDA 090199 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 090199
Tradename:LEVOCETIRIZINE DIHYDROCHLORIDE
Applicant:Teva Pharms
Ingredient:levocetirizine dihydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Pharmacology for NDA: 090199
Suppliers and Packaging for NDA: 090199
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 090199 ANDA Teva Pharmaceuticals USA, Inc. 0093-7701 0093-7701-98 90 TABLET, FILM COATED in 1 BOTTLE (0093-7701-98)
LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 090199 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-784 35356-784-90 90 TABLET, FILM COATED in 1 BOTTLE (35356-784-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 22, 2011TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Baxter
Accenture
Colorcon
Express Scripts
Healthtrust
Farmers Insurance
Merck
US Army

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