Oleptro FDA 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
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 timeline for Oleptro
| Date | Article |
|---|---|
| Feb 2, 2010 | Approval 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 |
Further information
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