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Oleptro Approval History

  • FDA approved: Yes (First approved February 2nd, 2010)
  • Brand name: Oleptro
  • Generic name: trazodone
  • Dosage form: Extended Release Tablets
  • Previous name: DDS-04A
  • Company: Labopharm Inc.
  • Treatment for: Depression, Major Depressive Disorder

Oleptro (trazodone) is a once-daily serotonin antagonist reuptake inhibitor (SARI) formulation for the treatment of major depressive disorder (MDD) in adults.

Development History and FDA Approval Process for Oleptro

Feb  2, 2010Approval Labopharm Receives FDA Approval for Oleptro
Nov 24, 2008Labopharm's NDA for Novel Trazodone Formulation Accepted for Review by FDA
Sep 22, 2008Labopharm Submits New Drug Application to FDA for DDS-04A to Treat Major Depression

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