Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207793

ONIVYDE (IRINOTECAN HYDROCHLORIDE)
EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) Marketing Status: Prescription

Active Ingredient: IRINOTECAN HYDROCHLORIDE
Proprietary Name: ONIVYDE
Dosage Form; Route of Administration: INJECTABLE, LIPOSOMAL; IV (INFUSION)
Strength: EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207793
Product Number: 001
Approval Date: Oct 22, 2015
Applicant Holder Full Name: IPSEN BIOPHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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