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Aurobindo Receives FDA Approval for Tretinoin Gel USP, 0.01%

Published: January 13, 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 Tretinoin Gel USP, 0.01%. Aurobindo Pharma’s Tretinoin Gel, are an AB-rated generic equivalent to the reference listed drug (RLD), Retin-A® Gel manufactured by Bausch Health US, LLC.

Tretinoin Gel are indicated for:

  • Topical application in the treatment of acne vulgaris.