General MedicationsORALStandard
BARACLUDE
ENTECAVIR
Standard Dose
0.05MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview BARACLUDE is listed in Drugs@FDA under application 021798 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ENTECAVIR Form and strength SOLUTION;ORAL - 0.05MG/ML Sponsor BRISTOL MYERS SQUIBB Submission history Latest submission status date: 2019-11-06 00:00:00.
Structured Monograph
Clinical summary
Approval overview BARACLUDE is listed in Drugs@FDA under application 021798 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ENTECAVIR Form and strength SOLUTION;ORAL - 0.05MG/ML Sponsor BRISTOL MYERS SQUIBB Submission history Latest submission status date: 2019-11-06 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.