General MedicationsINTRAVENOUSStandard

ONIVYDE

IRINOTECAN HYDROCHLORIDE

Standard Dose

EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview ONIVYDE is listed in Drugs@FDA under application 207793 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient IRINOTECAN HYDROCHLORIDE Form and strength INJECTABLE, LIPOSOMAL;INTRAVENOUS - EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) Sponsor IPSEN Submission history Latest submission status date: 2024-12-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview ONIVYDE is listed in Drugs@FDA under application 207793 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient IRINOTECAN HYDROCHLORIDE Form and strength INJECTABLE, LIPOSOMAL;INTRAVENOUS - EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) Sponsor IPSEN Submission history Latest submission status date: 2024-12-23 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.