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General MedicationsFILM COATEDGeneric

BOSUTINIB

BOSUTINIB MONOHYDRATE

Standard Dose
400MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview BOSUTINIB is listed in Drugs@FDA under application 209624 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient BOSUTINIB MONOHYDRATE Form and strength TABLET;FILM COATED - 400MG Sponsor MSN LABORATORIES PRIVATE LTD Submission history Latest submission status date: 2025-05-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview BOSUTINIB is listed in Drugs@FDA under application 209624 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient BOSUTINIB MONOHYDRATE Form and strength TABLET;FILM COATED - 400MG Sponsor MSN LABORATORIES PRIVATE LTD Submission history Latest submission status date: 2025-05-28 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: None (Tentative Approval)
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.