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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 091165

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NDA 091165 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-nine 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 suppliers are listed for this compound. Additional details are available on the eszopiclone profile page.

Summary for 091165

Tradename:	ESZOPICLONE
Applicant:	Chartwell Rx
Ingredient:	eszopiclone
Patents:	0

Medical Subject Heading (MeSH) Categories for 091165

Hypnotics and Sedatives

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Jul 14, 2011	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Jul 14, 2011	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	3MG
Approval Date:	Jul 14, 2011	TE:		RLD:	No

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