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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Healthtrust
Argus Health
AstraZeneca
Chinese Patent Office
Queensland Health
Harvard Business School
QuintilesIMS
Merck

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091166

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NDA 091166 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-five suppliers are listed for this compound. Additional details are available on the eszopiclone profile page.
Summary for 091166
Tradename:ESZOPICLONE
Applicant:Glenmark Generics
Ingredient:eszopiclone
Patents:0
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 091166
Suppliers and Packaging for NDA: 091166
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESZOPICLONE eszopiclone TABLET;ORAL 091166 ANDA Aidarex Pharmaceuticals LLC 53217-150 N 53217-150-30
ESZOPICLONE eszopiclone TABLET;ORAL 091166 ANDA DirectRX 61919-991 E 61919-991-90

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Apr 15, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Apr 15, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Apr 15, 2014TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Dow
Covington
AstraZeneca
Cerilliant
Daiichi Sankyo
Chubb
Farmers Insurance
Johnson and Johnson

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