Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205677

HETLIOZ (TASIMELTEON)
20MG Marketing Status: Prescription

Active Ingredient: TASIMELTEON
Proprietary Name: HETLIOZ
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205677
Product Number: 001
Approval Date: Jan 31, 2014
Applicant Holder Full Name: VANDA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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