General MedicationsORALStandard
SIROLIMUS
SIROLIMUS
Standard Dose
1MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview SIROLIMUS is listed in Drugs@FDA under application 214753 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient SIROLIMUS Form and strength TABLET;ORAL - 1MG Sponsor ALKEM LABS LTD Submission history Latest submission status date: 2023-04-04 00:00:00.
Structured Monograph
Clinical summary
Approval overview SIROLIMUS is listed in Drugs@FDA under application 214753 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SIROLIMUS Form and strength TABLET;ORAL - 1MG Sponsor ALKEM LABS LTD Submission history Latest submission status date: 2023-04-04 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.