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Details for New Drug Application (NDA): 091024

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NDA 091024 describes ESZOPICLONE, which is a drug marketed by Sun Pharma Global, Orchid Hlthcare, Dr Reddys Labs Ltd, Lupin Ltd, Macleods Pharms Ltd, Aurobindo Pharma Ltd, Mylan Pharms Inc, Roxane, Wockhardt Ltd, Glenmark Generics, and Teva, and is included in eleven NDAs. It is available from twenty-six 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-four suppliers are listed for this compound. Additional details are available on the eszopiclone profile page.

Summary for NDA: 091024

Dr Reddys Labs Ltd
Therapeutic Class:Sedatives/Hypnotics

Suppliers and Packaging for NDA: 091024

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 091024 ANDA Dr. Reddy's Laboratories Limited 55111-617 55111-617-01 100 TABLET, COATED in 1 BOTTLE (55111-617-01)
TABLET;ORAL 091024 ANDA Dr. Reddy's Laboratories Limited 55111-617 55111-617-05 500 TABLET, COATED in 1 BOTTLE (55111-617-05)

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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