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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
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Dow
US Department of Justice
McKesson
Express Scripts
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Covington

Generated: June 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201653

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NDA 201653 describes LEVOCETIRIZINE DIHYDROCHLORIDE, which is a drug marketed by Apotex Inc, Allied Pharma Inc, Synthon Pharms, Micro Labs Ltd India, 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 NDA: 201653

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

Pharmacology for NDA: 201653

Suppliers and Packaging for NDA: 201653

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
TABLET;ORAL 201653 ANDA Ranbaxy Pharmaceuticals Inc. 63304-433 63304-433-03 10 TABLET, FILM COATED in 1 BOTTLE (63304-433-03)
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
TABLET;ORAL 201653 ANDA Ranbaxy Pharmaceuticals Inc. 63304-433 63304-433-10 1000 TABLET, FILM COATED in 1 BOTTLE (63304-433-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 26, 2015TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Covington
Chubb
Daiichi Sankyo
Novartis
AstraZeneca
Farmers Insurance
Federal Trade Commission
McKinsey
Colorcon
QuintilesIMS

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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