Application 021164
- Type
- NDA
- Sponsor
- FABRE KRAMER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EXXUA | GEPIRONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 18.2MG BASE | Yes | Yes |
| 002 | EXXUA | GEPIRONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 36.3MG BASE | Yes | No |
| 003 | EXXUA | GEPIRONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 54.5MG BASE | Yes | No |
| 004 | EXXUA | GEPIRONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 72.6MG BASE | Yes | Yes |