General MedicationsORALGeneric
APIXABAN
APIXABAN
Standard Dose
2.5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary
Approval overview APIXABAN is listed in Drugs@FDA under application 218119 (ANDA).
Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient APIXABAN Form and strength TABLET; ORAL - 2.5MG Sponsor SCIEGEN PHARMACEUTICALS INC Submission history Latest submission status date: 2025-03-12 00:00:00.
Structured Monograph
Clinical summary
Approval overview APIXABAN is listed in Drugs@FDA under application 218119 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient APIXABAN Form and strength TABLET; ORAL - 2.5MG Sponsor SCIEGEN PHARMACEUTICALS INC Submission history Latest submission status date: 2025-03-12 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: None (Tentative Approval)
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.