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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207953

Marketing Status: Prescription
Active Ingredient: TRABECTEDIN
Proprietary Name: YONDELIS
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 1MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207953
Product Number: 001
Approval Date: Oct 23, 2015
Applicant Holder Full Name: JANSSEN PRODUCTS LP
Marketing Status:  Prescription
Patent and Exclusivity Information
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