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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 eleven 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-four suppliers are listed for this compound. Additional details are available on the eszopiclone profile page.

Summary for NDA: 021476

Tradename:
LUNESTA
Applicant:
Sunovion Pharms Inc
Ingredient:
eszopiclone
Patents:0
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details

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 Rebel Distributors Corp 21695-225 21695-225-30 30 TABLET, COATED in 1 BOTTLE (21695-225-30)
LUNESTA
eszopiclone
TABLET;ORAL 021476 NDA Rebel Distributors Corp 21695-226 21695-226-30 30 TABLET, COATED in 1 CARTON (21695-226-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Dec 15, 2004TE:ABRLD:No
Regulatory Exclusivity Expiration:Apr 10, 2016
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Oct 10, 2015
Regulatory Exclusivity Use:REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Dec 15, 2004TE:ABRLD:No
Regulatory Exclusivity Expiration:Apr 10, 2016
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

Expired Orange Book Patents for NDA: 021476

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sunovion Pharms Inc
LUNESTA
eszopiclone
TABLET;ORAL021476-002Dec 15, 20046,444,673*PED► subscribe
Sunovion Pharms Inc
LUNESTA
eszopiclone
TABLET;ORAL021476-001Dec 15, 20046,319,926*PED► subscribe
Sunovion Pharms Inc
LUNESTA
eszopiclone
TABLET;ORAL021476-002Dec 15, 20046,319,926*PED► subscribe
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