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General MedicationsINTRAVENOUSStandard

PALONOSETRON HYDROCHLORIDE

PALONOSETRON HYDROCHLORIDE

Standard Dose
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview PALONOSETRON HYDROCHLORIDE is listed in Drugs@FDA under application 215861 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient PALONOSETRON HYDROCHLORIDE Form and strength INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Sponsor MEITHEAL Submission history Latest submission status date: 2023-08-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview PALONOSETRON HYDROCHLORIDE is listed in Drugs@FDA under application 215861 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient PALONOSETRON HYDROCHLORIDE Form and strength INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Sponsor MEITHEAL Submission history Latest submission status date: 2023-08-14 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.