Application 125544
- Type
- BLA
- Sponsor
- CELLTRION INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | INFLECTRA | INFLIXIMAB-DYYB | INJECTABLE;INJECTION | 100MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0069-0809 | INFLECTRA | infliximab-dyyb | Pfizer Laboratories Div Pfizer Inc | BLA | Current |
| 0069-0809 | INFLECTRA | infliximab-dyyb | Pfizer Laboratories Div Pfizer Inc | BLA | Current |
| 0069-0809 | INFLECTRA | infliximab-dyyb | Pfizer Laboratories Div Pfizer Inc | BLA | Current |
| 0069-0809 | INFLECTRA | infliximab-dyyb | Pfizer Laboratories Div Pfizer Inc | BLA | Current |
| 0069-0809 | INFLECTRA | infliximab-dyyb | Pfizer Laboratories Div P | BLA | Current |
| 0069-0809 | INFLECTRA | infliximab-dyyb | Pfizer Laboratories Div Pfizer Inc | BLA | Current |
| 0069-0809 | INFLECTRA | infliximab-dyyb | Pfizer Laboratories Div Pfizer Inc | BLA | Current |
| 0069-0809 | INFLECTRA | infliximab-dyyb | Pfizer Laboratories Div Pfizer Inc | BLA | Current |
| 0069-0809 | INFLECTRA | infliximab-dyyb | Pfizer Laboratories Div Pfizer Inc | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83299 | SUPPL | 2025-09-05 |
| 83298 | SUPPL | 2025-09-05 |
| 83278 | SUPPL | 2025-09-04 |
| 67883 | SUPPL | 2021-06-24 |
| 67882 | SUPPL | 2021-06-24 |
| 59140 | SUPPL | 2019-06-20 |
| 59139 | SUPPL | 2019-06-20 |
| 59120 | SUPPL | 2019-06-19 |
| 57921 | SUPPL | 2019-03-07 |
| 55046 | SUPPL | 2018-07-30 |
| 22822 | ORIG | 2016-06-27 |
| 23470 | ORIG | 2016-04-27 |
| 31992 | ORIG | 2016-04-05 |
| 18933 | ORIG | 2016-04-05 |
| 51174 | ORIG | 1900-01-01 |
| 51173 | ORIG | 1900-01-01 |
| 51172 | ORIG | 1900-01-01 |