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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 091124


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NDA 091124 describes ESZOPICLONE, which is a drug marketed by Aurobindo Pharma, Chartwell Rx, Dr Reddys, Glenmark Generics, Hetero Labs Ltd V, Hikma, Ipca Labs Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Nostrum Labs Inc, Orbion Pharms, Sun Pharm, and Teva, and is included in fourteen 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-two suppliers are listed for this compound. Additional details are available on the eszopiclone profile page.
Summary for 091124
Tradename:ESZOPICLONE
Applicant:Lupin Ltd
Ingredient:eszopiclone
Patents:0
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 68180-322-01 100 TABLET, FILM COATED in 1 BOTTLE (68180-322-01)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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