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General MedicationsORALStandard

IMATINIB MESYLATE

IMATINIB MESYLATE

Standard Dose
EQ 400MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview IMATINIB MESYLATE is listed in Drugs@FDA under application 212975 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient IMATINIB MESYLATE Form and strength TABLET;ORAL - EQ 400MG BASE Sponsor HETERO LABS LTD V Submission history Latest submission status date: 2025-04-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview IMATINIB MESYLATE is listed in Drugs@FDA under application 212975 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient IMATINIB MESYLATE Form and strength TABLET;ORAL - EQ 400MG BASE Sponsor HETERO LABS LTD V Submission history Latest submission status date: 2025-04-14 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.