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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 091693

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: A091693
Product Number: 001
Approval Date: Jul 26, 2013
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status:  Prescription
Patent and Exclusivity Information
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