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Application 215309
- Type
- NDA
- Sponsor
- INCYTE CORP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OPZELURA | RUXOLITINIB | CREAM;TOPICAL | 1% | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50881-007 | OPZELURA | ruxolitinib | Incyte Corporation | NDA | Current |
| 50881-007 | OPZELURA | ruxolitinib | Incyte Corporation | NDA | Current |
| 50881-007 | OPZELURA | ruxolitinib | Incyte Corporation | NDA | Current |
| 50881-007 | OPZELURA | ruxolitinib | Incyte Corporation | NDA | Current |
| 50881-007 | OPZELURA | ruxolitinib | Incyte Corporation | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85858 | SUPPL | 2026-05-11 |
| 83398 | SUPPL | 2025-09-19 |
| 83397 | SUPPL | 2025-09-19 |
| 83395 | SUPPL | 2025-09-19 |
| 73759 | SUPPL | 2023-03-14 |
| 73741 | SUPPL | 2023-03-14 |
| 71593 | SUPPL | 2022-07-19 |
| 71592 | SUPPL | 2022-07-19 |
| 71589 | SUPPL | 2022-07-19 |
| 71552 | ORIG | 2022-07-14 |
| 71520 | ORIG | 2022-07-06 |
| 68716 | ORIG | 2021-09-22 |