Application 761061
- Type
- BLA
- Sponsor
- JANSSEN BIOTECH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TREMFYA | GUSELKUMAB | INJECTABLE;INJECTION | 100MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 57894-640 | Tremfya | Guselkumab | Janssen Biotech, Inc. | BLA | Current |
| 57894-640 | Tremfya | Guselkumab | Janssen Biotech, Inc. | BLA | Current |
| 57894-640 | Tremfya | Guselkumab | Janssen Biotech, Inc. | BLA | Current |
| 57894-640 | Tremfya | Guselkumab | Janssen Biotech, Inc. | BLA | Current |
| 57894-640 | Tremfya | Guselkumab | Janssen Biotech, Inc. | BLA | Current |
| 57894-640 | Tremfya | Guselkumab | Janssen Biotech, Inc. | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83599 | SUPPL | 2025-09-30 |
| 83598 | SUPPL | 2025-09-30 |
| 83581 | SUPPL | 2025-09-29 |
| 83580 | SUPPL | 2025-09-29 |
| 83578 | SUPPL | 2025-09-29 |
| 83416 | SUPPL | 2025-09-23 |
| 83407 | SUPPL | 2025-09-22 |
| 82595 | SUPPL | 2025-06-18 |
| 81737 | SUPPL | 2025-03-27 |
| 81736 | SUPPL | 2025-03-26 |
| 81682 | SUPPL | 2025-03-24 |
| 81674 | SUPPL | 2025-03-21 |
| 79622 | SUPPL | 2024-09-16 |
| 79580 | SUPPL | 2024-09-12 |
| 74680 | SUPPL | 2023-07-03 |
| 74668 | SUPPL | 2023-06-30 |
| 73850 | SUPPL | 2023-03-24 |
| 63961 | SUPPL | 2020-07-17 |
| 63893 | SUPPL | 2020-07-14 |
| 63409 | SUPPL | 2020-06-03 |
| 63406 | SUPPL | 2020-06-02 |
| 63405 | SUPPL | 2020-06-02 |
| 61097 | SUPPL | 2019-11-29 |
| 61096 | SUPPL | 2019-11-29 |
| 61054 | SUPPL | 2019-11-26 |
| 58230 | SUPPL | 2019-04-05 |
| 58228 | SUPPL | 2019-04-05 |
| 57376 | SUPPL | 2019-01-29 |
| 57374 | SUPPL | 2019-01-29 |
| 49466 | ORIG | 2017-08-21 |
| 48980 | ORIG | 2017-07-13 |
| 48978 | ORIG | 2017-07-13 |