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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
US Department of Justice
McKinsey
US Army
Baxter
Healthtrust
Cipla
Merck
Fish and Richardson
Express Scripts

Generated: November 23, 2017

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, Allied Pharma Inc, Synthon Pharms, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Sun Pharma Global, L Perrigo Co, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Taro Pharm Inds, Glenmark Generics, Sandoz, Dr Reddys Labs Ltd, Silarx Pharms Inc, 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 090392

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

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 55111-282-01 100 TABLET, COATED in 1 BOTTLE (55111-282-01)
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
TABLET;ORAL 090392 ANDA Dr.Reddy's laboratories Ltd. 55111-282 55111-282-05 500 TABLET, COATED in 1 BOTTLE (55111-282-05)

Summary 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:

QuintilesIMS
Moodys
Fish and Richardson
Harvard Business School
Dow
Covington
Argus Health
Chubb
Teva
UBS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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