BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Boehringer Ingelheim
Harvard Business School
US Army

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091124

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NDA 091124 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-seven suppliers are listed for this compound. Additional details are available on the eszopiclone profile page.

Summary for 091124

Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 091124

Suppliers and Packaging for NDA: 091124

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESZOPICLONE eszopiclone TABLET;ORAL 091124 ANDA PD-Rx Pharmaceuticals, Inc. 43063-795 43063-795-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-795-30)
ESZOPICLONE eszopiclone TABLET;ORAL 091124 ANDA Lupin Pharmaceuticals, Inc. 68180-322 68180-322-13 7 BLISTER PACK in 1 CARTON (68180-322-13) > 14 TABLET, FILM COATED in 1 BLISTER PACK (68180-322-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Sep 13, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Sep 13, 2011TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Sep 13, 2011TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

US Army
Argus Health
Federal Trade Commission
Chinese Patent Office
Cantor Fitzgerald

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