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

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Summary

FDA approved a supplemental application for simvastatin from NorthStar Rx LLC under ANDA 077691, granting approval for a change to the generic product.

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Diseases / indications

• Atherosclerotic Cardiovascular Disease
• Coronary Heart Disease
• Hyperlipidemia
• Stroke

Drugs mentioned

• SIMVASTATIN (SIMVASTATIN)

Snippet

SUPPL AP for SIMVASTATIN (SIMVASTATIN)