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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
US Army
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Chinese Patent Office
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Boehringer Ingelheim
Cerilliant
Accenture
UBS
QuintilesIMS

Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203646

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NDA 203646 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-eight 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-two suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.

Summary for NDA: 203646

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

Pharmacology for NDA: 203646

Suppliers and Packaging for NDA: 203646

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
TABLET;ORAL 203646 ANDA AvKARE, Inc. 42291-386 42291-386-90 90 TABLET in 1 BOTTLE (42291-386-90)
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
TABLET;ORAL 203646 ANDA Vensun Pharmaceuticals, Inc. 42543-712 42543-712-03 300 TABLET in 1 BOTTLE (42543-712-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Sep 9, 2014TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Queensland Health
Julphar
Cantor Fitzgerald
Cipla
Chubb
QuintilesIMS
Covington
Citi
Moodys

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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