Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021476

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LUNESTA (ESZOPICLONE)
1MG
Marketing Status: Prescription

Active Ingredient: ESZOPICLONE
Proprietary Name: LUNESTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021476
Product Number: 001
Approval Date: Dec 15, 2004
Applicant Holder Full Name: WAYLIS THERAPEUTICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

LUNESTA (ESZOPICLONE)
2MG
Marketing Status: Prescription

Active Ingredient: ESZOPICLONE
Proprietary Name: LUNESTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021476
Product Number: 002
Approval Date: Dec 15, 2004
Applicant Holder Full Name: WAYLIS THERAPEUTICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

LUNESTA (ESZOPICLONE)
3MG
Marketing Status: Prescription

Active Ingredient: ESZOPICLONE
Proprietary Name: LUNESTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021476
Product Number: 003
Approval Date: Dec 15, 2004
Applicant Holder Full Name: WAYLIS THERAPEUTICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information