Application 022411
- Type
- NDA
- Sponsor
- ANGELINI PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OLEPTRO | TRAZODONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | OLEPTRO | TRAZODONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |