Last Updated: June 25, 2026

Details for New Drug Application (NDA): 091103


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NDA 091103 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 091103
Tradename:ESZOPICLONE
Applicant:Sun Pharm
Ingredient:eszopiclone
Patents:0
Medical Subject Heading (MeSH) Categories for 091103
Hypnotics and Sedatives
Suppliers and Packaging for NDA: 091103
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESZOPICLONE eszopiclone TABLET;ORAL 091103 ANDA Sun Pharmaceutical Industries, Inc. 47335-586 47335-586-08 100 TABLET, FILM COATED in 1 BOTTLE (47335-586-08)
ESZOPICLONE eszopiclone TABLET;ORAL 091103 ANDA Sun Pharmaceutical Industries, Inc. 47335-586 47335-586-18 1000 TABLET, FILM COATED in 1 BOTTLE (47335-586-18)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Apr 3, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Apr 3, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Apr 3, 2013TE:ABRLD:No

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Preferred Citation:

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