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Details for New Drug Application (NDA): 091153

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NDA 091153 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: 091153

Therapeutic Class:Sedatives/Hypnotics

Suppliers and Packaging for NDA: 091153

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