Application 214487
- Type
- NDA
- Sponsor
- CHEMOCENTRYX, INC.
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TAVNEOS | AVACOPAN | CAPSULE;ORAL | 10MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 73556-168 | TAVNEOS | avacopan | ChemoCentryx, Inc. | NDA | Current |
| 73556-168 | TAVNEOS | avacopan | ChemoCentryx, Inc. | NDA | Current |
| 73556-168 | TAVNEOS | avacopan | ChemoCentryx, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 78629 | SUPPL | 2024-07-02 |
| 78762 | SUPPL | 2024-07-01 |
| 71528 | SUPPL | 2022-07-07 |
| 71524 | SUPPL | 2022-07-07 |
| 69223 | ORIG | 2021-11-04 |
| 68958 | ORIG | 2021-10-12 |
| 68957 | ORIG | 2021-10-12 |
| 68956 | ORIG | 2021-10-12 |