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Aurobindo Receives FDA Approval for Doxepin Tablets, 3 mg and 6 mg

Published: July 25, 2024

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Doxepin Tablets, 3 mg and 6 mg. Aurobindo Pharma’s Doxepin Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Silenor Tablets manufactured by Currax Pharmaceuticals LLC.

Doxepin Tablets are indicated for:

  • The treatment of insomnia characterized by difficulty with sleep maintenance.