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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 091151


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NDA 091151 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 091151
Tradename:ESZOPICLONE
Applicant:Mylan Pharms Inc
Ingredient:eszopiclone
Patents:0
Medical Subject Heading (MeSH) Categories for 091151
Hypnotics and Sedatives
Suppliers and Packaging for NDA: 091151
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESZOPICLONE eszopiclone TABLET;ORAL 091151 ANDA Mylan Pharmaceuticals Inc. 0378-5270 0378-5270-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5270-01)
ESZOPICLONE eszopiclone TABLET;ORAL 091151 ANDA Mylan Pharmaceuticals Inc. 0378-5271 0378-5271-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5271-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Mar 26, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Mar 26, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Mar 26, 2013TE:ABRLD:No

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Preferred Citation:

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