Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021782

ROZEREM (RAMELTEON)
8MG Marketing Status: Prescription

Active Ingredient: RAMELTEON
Proprietary Name: ROZEREM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 8MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021782
Product Number: 001
Approval Date: Jul 22, 2005
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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