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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091169

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NDA 091169 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 091169

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 091169

Suppliers and Packaging for NDA: 091169

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESZOPICLONE eszopiclone TABLET;ORAL 091169 ANDA Teva Pharmaceuticals USA, Inc. 0093-5537 0093-5537-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-5537-56)
ESZOPICLONE eszopiclone TABLET;ORAL 091169 ANDA Teva Pharmaceuticals USA, Inc. 0093-5538 0093-5538-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-5538-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:May 23, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:May 23, 2011TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:May 23, 2011TE:ABRLD:No


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