Active Ingredient: IRINOTECAN HYDROCHLORIDE
Proprietary Name: ONIVYDE
Dosage Form; Route of Administration: INJECTABLE, LIPOSOMAL; INTRAVENOUS
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