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Aurobindo Receives FDA Approval for Nystatin Cream USP, 100,000 units per gram

Published: March 21, 2025

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Nystatin Cream USP, 100,000 units per gram. Aurobindo Pharma’s Nystatin Cream, are an AB-rated generic equivalent to the reference listed drug (RLD), Nystatin Cream manufactured by Taro Pharmaceuticals Inc.,

Nystatin Cream are indicated in the treatment of:

  • Cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.