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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205525

Marketing Status: Prescription
Active Ingredient: DRONABINOL
Proprietary Name: SYNDROS
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 5MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205525
Product Number: 001
Approval Date: Mar 23, 2017
Applicant Holder Full Name: BENUVIA OPERATIONS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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