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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091153

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NDA 091153 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 091153

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

Medical Subject Heading (MeSH) Categories for 091153

Suppliers and Packaging for NDA: 091153

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESZOPICLONE eszopiclone TABLET;ORAL 091153 ANDA West-Ward Pharmaceuticals Corp. 0054-0290 0054-0290-13 30 TABLET in 1 BOTTLE (0054-0290-13)
ESZOPICLONE eszopiclone TABLET;ORAL 091153 ANDA West-Ward Pharmaceuticals Corp. 0054-0291 0054-0291-25 100 TABLET in 1 BOTTLE (0054-0291-25)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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