Application 210498
- Type
- NDA
- Sponsor
- ARRAY BIOPHARMA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MEKTOVI | BINIMETINIB | TABLET;ORAL | 15MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70255-010 | MEKTOVI | BINIMETINIB | Array BioPharma Inc. | NDA | Current |
| 70255-010 | MEKTOVI | BINIMETINIB | Array BioPharma Inc. | NDA | Current |
| 70255-010 | MEKTOVI | BINIMETINIB | Array BioPharma Inc. | NDA | Current |
| 70255-010 | MEKTOVI | BINIMETINIB | Array BioPharma Inc. | NDA | Current |
| 70255-010 | MEKTOVI | BINIMETINIB | Array BioPharma Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81579 | SUPPL | 2025-03-17 |
| 81578 | SUPPL | 2025-03-17 |
| 81565 | SUPPL | 2025-03-14 |
| 79616 | SUPPL | 2024-09-16 |
| 79590 | SUPPL | 2024-09-16 |
| 75722 | SUPPL | 2023-10-13 |
| 75712 | SUPPL | 2023-10-12 |
| 60092 | ORIG | 2019-09-23 |
| 60091 | ORIG | 2019-09-23 |
| 57548 | SUPPL | 2019-02-13 |
| 54696 | SUPPL | 2019-01-23 |
| 55266 | ORIG | 2018-08-22 |