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Application 761072
- Type
- BLA
- Sponsor
- PFIZER INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IXIFI | INFLIXIMAB-QBTX | INJECTABLE;INJECTION | 100MG/VIAL | Yes | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83725 | SUPPL | 2025-10-10 |
| 83711 | SUPPL | 2025-10-09 |
| 83710 | SUPPL | 2025-10-09 |
| 77165 | SUPPL | 2023-12-28 |
| 77144 | SUPPL | 2023-12-27 |
| 61579 | SUPPL | 2020-01-15 |
| 61578 | SUPPL | 2020-01-15 |
| 61577 | SUPPL | 2020-01-15 |
| 56584 | ORIG | 2018-11-29 |
| 50752 | ORIG | 2017-12-18 |
| 50680 | ORIG | 2017-12-13 |