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FDA NDA · NDA207793

ONIVYDE

irinotecan hydrochloride

Sponsor: IPSEN

APPLICATION
NDA207793
TYPE
NDA
ORIGINAL APPROVAL
2015-10-22
LATEST ACTION
2024-12-23
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE, LIPOSOMAL
MARKETING STATUS
Prescription

Products

ONIVYDE · ReferencePrescription
IRINOTECAN HYDROCHLORIDE EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) · INJECTABLE, LIPOSOMAL · INTRAVENOUS

Approval history

2024-12-23Labeling · Supplement 18 · standard — Letter ↗AP
2024-02-13Efficacy · Supplement 16 · standard — Label ↗AP
2023-02-03Labeling · Supplement 15 · standard — Letter ↗AP
2015-10-22Type 5 - New Formulation or New Manufacturer · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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