Application 019546
- Type
- NDA
- Sponsor
- SMITHKLINE BEECHAM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DYNACIRC | ISRADIPINE | CAPSULE;ORAL | 2.5MG | Yes | No |
| 002 | DYNACIRC | ISRADIPINE | CAPSULE;ORAL | 5MG | Yes | No |
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DYNACIRC | ISRADIPINE | CAPSULE;ORAL | 2.5MG | Yes | No |
| 002 | DYNACIRC | ISRADIPINE | CAPSULE;ORAL | 5MG | Yes | No |