Application 205874
- Type
- NDA
- Sponsor
- KERYX BIOPHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AURYXIA | FERRIC CITRATE | TABLET;ORAL | EQ 210MG IRON | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59922-631 | Auryxia | ferric citrate | Akebia Therapeutics, Inc. | NDA | Current |
| 59922-631 | Auryxia | ferric citrate | Akebia Therapeutics, Inc. | NDA | Current |
| 59922-631 | Auryxia | ferric citrate | Akebia Therapeutics, Inc. | NDA | Current |
| 59922-631 | Auryxia | ferric citrate | Keryx Biopharmaceuticals, Inc. | NDA | Current |
| 59922-631 | Auryxia | ferric citrate | Keryx Biopharmaceuticals, Inc. | NDA | Current |
| 59922-631 | Auryxia | ferric citrate | Keryx Biopharmaceuticals, Inc. | NDA | Current |
| 59922-631 | Auryxia | ferric citrate | Keryx Biopharmaceuticals, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77273 | SUPPL | 2024-01-23 |
| 77257 | SUPPL | 2024-01-22 |
| 66738 | SUPPL | 2021-03-11 |
| 66734 | SUPPL | 2021-03-11 |
| 50352 | SUPPL | 2017-11-09 |
| 50319 | SUPPL | 2017-11-06 |
| 32761 | SUPPL | 2015-07-23 |
| 19696 | SUPPL | 2015-07-22 |
| 44936 | ORIG | 2015-04-22 |
| 23008 | ORIG | 2015-04-22 |
| 19695 | SUPPL | 2014-11-20 |
| 32760 | SUPPL | 2014-11-17 |
| 19694 | ORIG | 2014-09-09 |
| 10523 | ORIG | 2014-09-08 |