General MedicationsORALStandard
RIVAROXABAN
RIVAROXABAN
Standard Dose
1MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview RIVAROXABAN is listed in Drugs@FDA under application 218502 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient RIVAROXABAN Form and strength FOR SUSPENSION;ORAL - 1MG/ML Sponsor ALKEM LABS LTD Submission history Latest submission status date: 2025-06-26 00:00:00.
Structured Monograph
Clinical summary
Approval overview RIVAROXABAN is listed in Drugs@FDA under application 218502 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient RIVAROXABAN Form and strength FOR SUSPENSION;ORAL - 1MG/ML Sponsor ALKEM LABS LTD Submission history Latest submission status date: 2025-06-26 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.