Application 216793
- Type
- NDA
- Sponsor
- JANSSEN BIOTECH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AKEEGA | ABIRATERONE ACETATE; NIRAPARIB TOSYLATE | TABLET;ORAL | 500MG;EQ 50MG BASE | Yes | No |
| 002 | AKEEGA | ABIRATERONE ACETATE; NIRAPARIB TOSYLATE | TABLET;ORAL | 500MG;EQ 100MG BASE | Yes | Yes |