Application 216340
- Type
- NDA
- Sponsor
- MIRATI THERAPEUTICS, INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | KRAZATI (ADAGRASIB) | ADAGRASIB | TABLET;ORAL | 200mg | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 80739-812 | KRAZATI | adagrasib | Mirati Therapeutics, Inc | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85544 | SUPPL | 2026-03-27 |
| 85543 | SUPPL | 2026-03-27 |
| 80194 | SUPPL | 2024-11-12 |
| 79124 | SUPPL | 2024-07-18 |
| 78862 | SUPPL | 2024-06-21 |
| 73141 | ORIG | 2023-01-11 |
| 72870 | ORIG | 2022-12-13 |
| 72869 | ORIG | 2022-12-12 |