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