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General MedicationsINTRAVENOUSGeneric

ALOXI

PALONOSETRON HYDROCHLORIDE

Standard Dose
EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview ALOXI is listed in Drugs@FDA under application 021372 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient PALONOSETRON HYDROCHLORIDE Form and strength INJECTABLE;INTRAVENOUS - EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor HELSINN HLTHCARE Submission history Latest submission status date: 2020-04-01 00:00:00.

Structured Monograph

Clinical summary

Approval overview ALOXI is listed in Drugs@FDA under application 021372 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient PALONOSETRON HYDROCHLORIDE Form and strength INJECTABLE;INTRAVENOUS - EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor HELSINN HLTHCARE Submission history Latest submission status date: 2020-04-01 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.