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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 021476

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NDA 021476 describes LUNESTA, which is a drug marketed by Waylis Therap and is included in one NDA. It is available from one supplier. Additional details are available on the LUNESTA profile page.

The generic ingredient in LUNESTA 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 021476

Tradename:	LUNESTA
Applicant:	Waylis Therap
Ingredient:	eszopiclone
Patents:	0

Medical Subject Heading (MeSH) Categories for 021476

Hypnotics and Sedatives

Suppliers and Packaging for NDA: 021476

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LUNESTA	eszopiclone	TABLET;ORAL	021476	NDA	Waylis Therapeutics LLC	80725-010	80725-010-30	30 TABLET, COATED in 1 BOTTLE (80725-010-30)
LUNESTA	eszopiclone	TABLET;ORAL	021476	NDA	Waylis Therapeutics LLC	80725-011	80725-011-30	30 TABLET, COATED in 1 BOTTLE (80725-011-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Dec 15, 2004	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Dec 15, 2004	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	3MG
Approval Date:	Dec 15, 2004	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021476

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-002	Dec 15, 2004	⤷ Get Started Free	⤷ Get Started Free
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-003	Dec 15, 2004	⤷ Get Started Free	⤷ Get Started Free
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-001	Dec 15, 2004	⤷ Get Started Free	⤷ Get Started Free
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-002	Dec 15, 2004	⤷ Get Started Free	⤷ Get Started Free
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-003	Dec 15, 2004	⤷ Get Started Free	⤷ Get Started Free
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-002	Dec 15, 2004	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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