Application 213082
- Type
- NDA
- Sponsor
- PFIZER INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XELJANZ | TOFACITINIB | SOLUTION; ORAL | 5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0069-1029 | XELJANZ | tofacitinib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-1029 | XELJANZ | tofacitinib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-1029 | XELJANZ | tofacitinib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-1029 | XELJANZ | tofacitinib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-1029 | XELJANZ | tofacitinib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-1029 | XELJANZ | tofacitinib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-1029 | XELJANZ | tofacitinib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-1029 | XELJANZ | tofacitinib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-1029 | XELJANZ | tofacitinib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85323 | SUPPL | 2026-03-11 |
| 85303 | SUPPL | 2026-03-09 |
| 85349 | SUPPL | 2026-03-06 |
| 83841 | SUPPL | 2025-10-21 |
| 83814 | SUPPL | 2025-10-20 |
| 81360 | SUPPL | 2025-02-25 |
| 81335 | SUPPL | 2025-02-24 |
| 79784 | SUPPL | 2024-09-30 |
| 79783 | SUPPL | 2024-09-30 |
| 79772 | SUPPL | 2024-09-30 |
| 78511 | SUPPL | 2024-05-20 |
| 78482 | SUPPL | 2024-05-15 |
| 69590 | SUPPL | 2021-12-16 |
| 69567 | SUPPL | 2021-12-15 |
| 69566 | SUPPL | 2021-12-15 |
| 69482 | SUPPL | 2021-12-06 |
| 69471 | SUPPL | 2021-12-03 |
| 69470 | SUPPL | 2021-12-03 |
| 65049 | ORIG | 2020-10-29 |
| 64742 | ORIG | 2020-09-29 |
| 64741 | ORIG | 2020-09-29 |
| 64740 | ORIG | 2020-09-29 |