General MedicationsINTRAVENOUSStandard

AKYNZEO

FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

Standard Dose

EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview AKYNZEO is listed in Drugs@FDA under application 210493 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML) Sponsor HELSINN HLTHCARE Submission history Latest submission status date: 2023-02-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview AKYNZEO is listed in Drugs@FDA under application 210493 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML) Sponsor HELSINN HLTHCARE Submission history Latest submission status date: 2023-02-15 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.