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Serving leading biopharmaceutical companies globally:

US Army
Cipla
Express Scripts
Cantor Fitzgerald
Daiichi Sankyo
Julphar
Baxter
AstraZeneca
Harvard Business School
Cerilliant

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202929

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NDA 202929 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 202929
Tradename:ESZOPICLONE
Applicant:Macleods Pharms Ltd
Ingredient:eszopiclone
Patents:0
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 202929
Suppliers and Packaging for NDA: 202929
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESZOPICLONE eszopiclone TABLET;ORAL 202929 ANDA Macleods Pharmaceuticals Limited 33342-299 N 33342-299-07
ESZOPICLONE eszopiclone TABLET;ORAL 202929 ANDA Macleods Pharmaceuticals Limited 33342-299 N 33342-299-12

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jan 30, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jan 30, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Jan 30, 2015TE:ABRLD:No

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McKinsey
Covington
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Mallinckrodt
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US Army
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