Application 214622
- Type
- NDA
- Sponsor
- QED THERAPEUTICS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TRUSELTIQ | INFIGRATINIB | CAPSULE;ORAL | 25MG | Yes | No |
| 002 | TRUSELTIQ | INFIGRATINIB | CAPSULE;ORAL | 100MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 72730-101 | TRUSELTIQ | infigratinib | QED Therapeutics, Inc. | NDA | Current |
| 72730-101 | TRUSELTIQ | infigratinib | QED Therapeutics, Inc. | NDA | Current |
| 72730-101 | TRUSELTIQ | infigratinib | QED Therapeutics, Inc. | NDA | Current |
| 72730-111 | TRUSELTIQ | infigratinib | QED Therapeutics, Inc. | NDA | Current |
| 72730-111 | TRUSELTIQ | infigratinib | QED Therapeutics, Inc. | NDA | Current |
| 72730-111 | TRUSELTIQ | infigratinib | QED Therapeutics, Inc. | NDA | Current |
| 72730-202 | TRUSELTIQ | infigratinib | QED Therapeutics, Inc. | NDA | Current |
| 72730-202 | TRUSELTIQ | infigratinib | QED Therapeutics, Inc. | NDA | Current |
| 72730-202 | TRUSELTIQ | infigratinib | QED Therapeutics, Inc. | NDA | Current |
| 72730-506 | TRUSELTIQ | infigratinib | QED Therapeutics, Inc. | NDA | Current |
| 72730-506 | TRUSELTIQ | infigratinib | QED Therapeutics, Inc. | NDA | Current |
| 72730-506 | TRUSELTIQ | infigratinib | QED Therapeutics, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 67905 | ORIG | 2021-06-25 |
| 67635 | ORIG | 2021-06-01 |
| 67630 | ORIG | 2021-05-28 |