FDA Approved: SIMVASTATIN — Supplemental Application (Micro Labs Limited)

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Summary

FDA approved a supplemental application for simvastatin by Micro Labs Limited under ANDA090383, updating the regulatory status of the approved generic product.

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Diseases / indications

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

Drugs mentioned

• SIMVASTATIN (SIMVASTATIN)

Snippet

SUPPL AP for SIMVASTATIN (SIMVASTATIN)