FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

View source ↗

Summary

FDA approved a supplemental application for simvastatin from NorthStar Rx LLC under the ANDA framework, supporting continued regulatory status for this generic …

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

• Atherosclerotic Cardiovascular Disease
• Coronary Heart Disease
• Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipidemia

Drugs mentioned

• SIMVASTATIN (SIMVASTATIN)

Snippet

SUPPL AP for SIMVASTATIN (SIMVASTATIN)