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General MedicationsORALStandard

ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE

Standard Dose
EQ 4MG BASE/5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ONDANSETRON HYDROCHLORIDE is listed in Drugs@FDA under application 091483 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ONDANSETRON HYDROCHLORIDE Form and strength SOLUTION;ORAL - EQ 4MG BASE/5ML Sponsor AMNEAL PHARMS Submission history Latest submission status date: 2025-09-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview ONDANSETRON HYDROCHLORIDE is listed in Drugs@FDA under application 091483 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ONDANSETRON HYDROCHLORIDE Form and strength SOLUTION;ORAL - EQ 4MG BASE/5ML Sponsor AMNEAL PHARMS Submission history Latest submission status date: 2025-09-15 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.