Application 213973
- Type
- NDA
- Sponsor
- DECIPHERA PHARMACEUTICALS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | QINLOCK | RIPRETINIB | TABLET;ORAL | 150MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 73207-101 | QINLOCK | Ripretinib | Deciphera Pharmaceuticals, LLC | NDA | Current |
| 73207-101 | QINLOCK | Ripretinib | Deciphera Pharmaceuticals, LLC | NDA | Current |
| 73207-101 | QINLOCK | Ripretinib | Deciphera Pharmaceuticals, LLC | NDA | Current |
| 73207-101 | QINLOCK | Ripretinib | Decipera Pharmaceuticals, LLC | NDA | Current |
| 73207-101 | QINLOCK | Ripretinib | Deciphera Pharmaceuticals, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82166 | SUPPL | 2025-05-08 |
| 82209 | SUPPL | 2025-05-06 |
| 75978 | SUPPL | 2023-10-27 |
| 75963 | SUPPL | 2023-10-27 |
| 73076 | SUPPL | 2023-01-04 |
| 73067 | SUPPL | 2023-01-03 |
| 72109 | SUPPL | 2022-09-19 |
| 72092 | SUPPL | 2022-09-16 |
| 67864 | SUPPL | 2021-06-22 |
| 67853 | SUPPL | 2021-06-22 |
| 63589 | ORIG | 2020-06-17 |
| 63093 | ORIG | 2020-05-19 |
| 63053 | ORIG | 2020-05-15 |