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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212650

RAMELTEON (RAMELTEON)
8MG
Marketing Status: Prescription
Active Ingredient: RAMELTEON
Proprietary Name: RAMELTEON
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 8MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212650
Product Number: 001
Approval Date: Apr 10, 2020
Applicant Holder Full Name: I3 PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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