Application 214916
- Type
- NDA
- Sponsor
- CARA THERAPEUTICS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | KORSUVA | DIFELIKEFALIN | SOLUTION;INTRAVENOUS | 65MCG/1.3ML (50MCG/ML) | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59353-065 | Korsuva | Difelikefalin | Vifor (International) Inc. | NDA | Current |
| 59353-065 | Korsuva | Difelikefalin | Vifor (International) Inc. | NDA | Current |
| 59353-065 | Korsuva | Difelikefalin | Vifor (International) Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83909 | SUPPL | 2025-10-24 |
| 68656 | ORIG | 2021-09-20 |
| 68457 | ORIG | 2021-08-25 |
| 68452 | ORIG | 2021-08-24 |