Application 214958
- Type
- NDA
- Sponsor
- BRISTOL-MYERS SQUIBB
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SOTYKTU | DEUCRAVACITINIB | TABLET; ORAL | 6MG (3) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0003-0895 | SOTYKTU | deucravacitinib | E.R. Squibb & Sons, L.L.C. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85341 | SUPPL | 2026-03-12 |
| 85307 | SUPPL | 2026-03-09 |
| 85357 | SUPPL | 2026-03-06 |
| 72322 | ORIG | 2022-10-14 |
| 72070 | ORIG | 2022-09-13 |
| 72069 | ORIG | 2022-09-13 |
| 72067 | ORIG | 2022-09-12 |