Oleptro Approval History
FDA Approved: Yes (Discontinued) (First approved February 2, 2010)
Brand name: Oleptro
Generic name: trazodone
Dosage form: Extended Release Tablets
Company: Labopharm Inc.
Treatment for: Depression, Major Depressive Disorder
Marketing Status: Discontinued
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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