General MedicationsORALStandard
ENVARSUS XR
TACROLIMUS
Standard Dose
EQ 0.75MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ENVARSUS XR is listed in Drugs@FDA under application 206406 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient TACROLIMUS Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 0.75MG BASE Sponsor VELOXIS PHARMS INC Submission history Latest submission status date: 2024-04-08 00:00:00.
Structured Monograph
Clinical summary
Approval overview ENVARSUS XR is listed in Drugs@FDA under application 206406 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TACROLIMUS Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 0.75MG BASE Sponsor VELOXIS PHARMS INC Submission history Latest submission status date: 2024-04-08 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.