Application 216158
- Type
- NDA
- Sponsor
- BRISTOL-MYERS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | COBENFY | TROSPIUM CHLORIDE; XANOMELINE TARTRATE | CAPSULE;ORAL | 20MG;EQ 50MG BASE | Yes | Yes |
| 002 | COBENFY | TROSPIUM CHLORIDE; XANOMELINE TARTRATE | CAPSULE;ORAL | 20MG;EQ 100MG BASE | Yes | No |
| 003 | COBENFY | TROSPIUM CHLORIDE; XANOMELINE TARTRATE | CAPSULE;ORAL | 30MG;EQ 125MG BASE | Yes | No |