Application 212763
- Type
- ANDA
- Sponsor
- ALVOGEN PINE BROOK
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IBRUTINIB | IBRUTINIB | UNKNOWN | UNKNOWN | No | No |
| 002 | IBRUTINIB | IBRUTINIB | TABLET;ORAL | 280MG | No | No |
| 003 | IBRUTINIB | IBRUTINIB | TABLET;ORAL | 420MG | No | No |
| 004 | IBRUTINIB | IBRUTINIB | TABLET;ORAL | 560MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 67425 | ORIG | 2021-05-06 |