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Aurobindo Receives FDA Approval for Ramelteon Tablets, 8 mg.

Published: July 11, 2023

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for Aurobindo Receives FDA Approval Ramelteon Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), ROZEREM® Tablets manufactured by Takeda Pharmaceuticals USA Inc.

Ramelteon Tablets, are indicated for :

  • Treatment of insomnia characterized by difficulty with sleep onset.