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Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Julphar
US Department of Justice
Covington
McKesson
Queensland Health
UBS
Dow
Cerilliant

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208451

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NDA 208451 describes ESZOPICLONE, which is a drug marketed by Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Glenmark Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Orchid Hlthcare, Sun Pharma Global, Teva, West-ward Pharms Int, and Wockhardt Ltd, and is included in eleven NDAs. It is available from thirty suppliers. Additional details are available on the ESZOPICLONE profile page.

The generic ingredient in ESZOPICLONE is eszopiclone. There are twenty drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the eszopiclone profile page.
Summary for 208451
Tradename:ESZOPICLONE
Applicant:Aurobindo Pharma Ltd
Ingredient:eszopiclone
Patents:0
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 208451
Suppliers and Packaging for NDA: 208451
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESZOPICLONE eszopiclone TABLET;ORAL 208451 ANDA Aurobindo Pharma Limited 65862-967 65862-967-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-967-01)
ESZOPICLONE eszopiclone TABLET;ORAL 208451 ANDA Aurobindo Pharma Limited 65862-967 65862-967-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-967-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Sep 15, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Sep 15, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Sep 15, 2016TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Accenture
Fish and Richardson
Farmers Insurance
Cerilliant
Queensland Health
Merck
Julphar
QuintilesIMS
Chinese Patent Office

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