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General MedicationsORALStandard

ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE

Standard Dose
EQ 4MG BASE
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 203761 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ONDANSETRON HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 4MG BASE Sponsor IPCA LABS LTD Submission history Latest submission status date: 2018-03-07 00:00:00.

Structured Monograph

Clinical summary

Approval overview ONDANSETRON HYDROCHLORIDE is listed in Drugs@FDA under application 203761 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ONDANSETRON HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 4MG BASE Sponsor IPCA LABS LTD Submission history Latest submission status date: 2018-03-07 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.