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General MedicationsORALStandard

SUNITINIB MALATE

SUNITINIB MALATE

Standard Dose
EQ 12.5MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SUNITINIB MALATE is listed in Drugs@FDA under application 218615 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient SUNITINIB MALATE Form and strength CAPSULE;ORAL - EQ 12.5MG BASE Sponsor EUGIA PHARMA Submission history Latest submission status date: 2024-03-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview SUNITINIB MALATE is listed in Drugs@FDA under application 218615 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SUNITINIB MALATE Form and strength CAPSULE;ORAL - EQ 12.5MG BASE Sponsor EUGIA PHARMA Submission history Latest submission status date: 2024-03-14 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.