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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 091113


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NDA 091113 describes ESZOPICLONE, which is a drug marketed by Aurobindo Pharma, Chartwell Rx, Dr Reddys, Glenmark Pharms Ltd, Hetero Labs Ltd V, Hikma, Ipca Labs Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Orbion Pharms, Pharmobedient, Sun Pharm, and Teva, and is included in fourteen NDAs. It is available from twenty-eight 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. Twenty-nine suppliers are listed for this compound. Additional details are available on the eszopiclone profile page.
Summary for 091113
Tradename:ESZOPICLONE
Applicant:Orbion Pharms
Ingredient:eszopiclone
Patents:0
Medical Subject Heading (MeSH) Categories for 091113
Hypnotics and Sedatives
Suppliers and Packaging for NDA: 091113
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESZOPICLONE eszopiclone TABLET;ORAL 091113 ANDA Bionpharma Inc. 69452-347 69452-347-13 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-347-13)
ESZOPICLONE eszopiclone TABLET;ORAL 091113 ANDA Bionpharma Inc. 69452-347 69452-347-20 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-347-20)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jun 10, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jun 10, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Jun 10, 2014TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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