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Last Updated: May 19, 2022

Details for New Drug Application (NDA): 021476


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NDA 021476 describes LUNESTA, which is a drug marketed by Sunovion Pharms Inc and is included in one NDA. It is available from two suppliers. 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-one suppliers are listed for this compound. Additional details are available on the eszopiclone profile page.
Summary for 021476
Tradename:LUNESTA
Applicant:Sunovion Pharms Inc
Ingredient:eszopiclone
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021476
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 PD-Rx Pharmaceuticals, Inc. 55289-014 55289-014-30 30 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-014-30)
LUNESTA eszopiclone TABLET;ORAL 021476 NDA Sunovion Pharmaceuticals Inc. 63402-190 63402-190-30 30 TABLET, COATED in 1 BOTTLE (63402-190-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Dec 15, 2004TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Dec 15, 2004TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Dec 15, 2004TE:ABRLD:Yes

Expired US Patents for NDA 021476

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sunovion Pharms Inc LUNESTA eszopiclone TABLET;ORAL 021476-003 Dec 15, 2004 See Plans and Pricing See Plans and Pricing
Sunovion Pharms Inc LUNESTA eszopiclone TABLET;ORAL 021476-001 Dec 15, 2004 See Plans and Pricing See Plans and Pricing
Sunovion Pharms Inc LUNESTA eszopiclone TABLET;ORAL 021476-002 Dec 15, 2004 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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