General MedicationsORALStandard
BOSUTINIB MONOHYDRATE
BOSUTINIB MONOHYDRATE
Standard Dose
EQ 100MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: UNKNOWN Marketing status: Prescription
Summary
Approval overview BOSUTINIB MONOHYDRATE is listed in Drugs@FDA under application 209543 (ANDA).
Review priority: UNKNOWN Marketing status: Prescription Active ingredient BOSUTINIB MONOHYDRATE Form and strength TABLET;ORAL - EQ 100MG BASE Sponsor ALEMBIC Submission history Latest submission status date: 2026-01-09 00:00:00.
Structured Monograph
Clinical summary
Approval overview BOSUTINIB MONOHYDRATE is listed in Drugs@FDA under application 209543 (ANDA). Review priority: UNKNOWN Marketing status: Prescription Active ingredient BOSUTINIB MONOHYDRATE Form and strength TABLET;ORAL - EQ 100MG BASE Sponsor ALEMBIC Submission history Latest submission status date: 2026-01-09 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: UNKNOWN
Interaction Notes
- No interaction notes stored yet.