Application 215341
- Type
- NDA
- Sponsor
- BAYER HEALTHCARE PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | KERENDIA | FINERENONE | TABLET; ORAL | 10MG | No | No |
| 002 | KERENDIA | FINERENONE | TABLET; ORAL | 20MG | No | No |
| 003 | KERENDIA | FINERENONE | TABLET;ORAL | 40MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50419-540 | Kerendia | finerenone | Bayer Healthcare Pharmaceuticals Inc. | NDA | Current |
| 50419-540 | Kerendia | finerenone | Bayer Healthcare Pharmaceuticals Inc. | NDA | Current |
| 50419-540 | Kerendia | finerenone | Bayer Healthcare Pharmaceuticals Inc. | NDA | Current |
| 50419-540 | Kerendia | finerenone | Bayer Healthcare Pharmaceuticals Inc. | NDA | Current |
| 50419-540 | Kerendia | finerenone | Bayer Healthcare Pharmaceuticals Inc. | NDA | Current |
| 50419-541 | Kerendia | finerenone | Bayer Healthcare Pharmaceuticals Inc. | NDA | Current |
| 50419-541 | Kerendia | finerenone | Bayer Healthcare Pharmaceuticals Inc. | NDA | Current |
| 50419-541 | Kerendia | finerenone | Bayer Healthcare Pharmaceuticals Inc. | NDA | Current |
| 50419-541 | Kerendia | finerenone | Bayer Healthcare Pharmaceuticals Inc. | NDA | Current |
| 50419-541 | Kerendia | finerenone | Bayer Healthcare Pharmaceuticals Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82856 | SUPPL | 2026-05-12 |
| 82867 | SUPPL | 2025-07-15 |
| 72002 | SUPPL | 2022-09-02 |
| 71995 | SUPPL | 2022-09-02 |
| 68296 | ORIG | 2021-08-05 |
| 68048 | ORIG | 2021-07-12 |
| 68045 | ORIG | 2021-07-12 |