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Generated: January 23, 2019

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Details for New Drug Application (NDA): 207793

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NDA 207793 describes ONIVYDE, which is a drug marketed by Ipsen Inc and is included in one NDA. It is available from two suppliers. There are twelve patents protecting this drug. Additional details are available on the ONIVYDE profile page.

The generic ingredient in ONIVYDE is irinotecan hydrochloride. There are thirty-three drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.
Summary for 207793
Tradename:ONIVYDE
Applicant:Ipsen Inc
Ingredient:irinotecan hydrochloride
Patents:12
Formulation / Manufacturing:see details
Pharmacology for NDA: 207793
Mechanism of ActionTopoisomerase Inhibitors
Suppliers and Packaging for NDA: 207793
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;INTRAVENOUS 207793 NDA Ipsen Biopharmaceuticals, Inc. 15054-0043 15054-0043-1 1 VIAL, SINGLE-DOSE in 1 CARTON (15054-0043-1) > 10 mL in 1 VIAL, SINGLE-DOSE
ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;INTRAVENOUS 207793 NDA Merrimack Pharmaceuticals 69171-398 69171-398-01 10 mL in 1 VIAL (69171-398-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE, LIPOSOMAL;INTRAVENOUSStrengthEQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)
Approval Date:Oct 22, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 22, 2022
Regulatory Exclusivity Use:FOR USE IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN, FOR THE TREATMENT OF PATIENTS WITH METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED FOLLOWING GEMCITABINE-BASED THERAPY
Regulatory Exclusivity Expiration:Oct 22, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Try a Free TrialPatent Expiration:Aug 29, 2028Product Flag?YSubstance Flag?YDelist Request?

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