CardiovascularORALGeneric
EZETIMIBE AND SIMVASTATIN
EZETIMIBE; SIMVASTATIN
Standard Dose
10MG;10MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary
Approval overview EZETIMIBE AND SIMVASTATIN is listed in Drugs@FDA under application 211663 (ANDA).
Review priority: STANDARD Marketing status: Discontinued Active ingredient EZETIMIBE; SIMVASTATIN Form and strength TABLET;ORAL - 10MG;10MG Sponsor SCIEGEN PHARMS Submission history Latest submission status date: 2024-12-10 00:00:00.
Structured Monograph
Clinical summary
Approval overview EZETIMIBE AND SIMVASTATIN is listed in Drugs@FDA under application 211663 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient EZETIMIBE; SIMVASTATIN Form and strength TABLET;ORAL - 10MG;10MG Sponsor SCIEGEN PHARMS Submission history Latest submission status date: 2024-12-10 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Discontinued
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.