Application 210496
- Type
- NDA
- Sponsor
- ARRAY BIOPHARMA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BRAFTOVI | ENCORAFENIB | CAPSULE;ORAL | 50MG | Yes | No |
| 002 | BRAFTOVI | ENCORAFENIB | CAPSULE;ORAL | 75MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70255-020 | BRAFTOVI | Encorafenib | Array BioPharma Inc. | NDA | Current |
| 70255-020 | BRAFTOVI | Encorafenib | Array BioPharma Inc. | NDA | Current |
| 70255-025 | BRAFTOVI | Encorafenib | Array BioPharma Inc. | NDA | Current |
| 70255-025 | BRAFTOVI | Encorafenib | Array BioPharma Inc. | NDA | Current |
| 70255-025 | BRAFTOVI | Encorafenib | Array BioPharma Inc. | NDA | Current |
| 70255-025 | BRAFTOVI | Encorafenib | Array BioPharma Inc. | NDA | Current |
| 70255-025 | BRAFTOVI | Encorafenib | Array BioPharma Inc. | NDA | Current |
| 70255-025 | BRAFTOVI | Encorafenib | Array BioPharma Inc. | NDA | Current |
| 70255-025 | BRAFTOVI | Encorafenib | Array BioPharma Inc. | NDA | Current |
| 70255-025 | BRAFTOVI | Encorafenib | Array BioPharma Inc. | NDA | Current |
| 70255-025 | BRAFTOVI | Encorafenib | Array BioPharma Inc. | NDA | Current |
| 70255-025 | BRAFTOVI | Encorafenib | Array BioPharma Inc. | NDA | Current |