Skip to content
Application 761086
- Type
- BLA
- Sponsor
- AMGEN INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AVSOLA | INFLIXIMAB-AXXQ | INJECTABLE;INJECTION | 100MG/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55513-670 | AVSOLA | infliximab-axxq | Amgen Inc | BLA | Current |
| 55513-670 | AVSOLA | infliximab-axxq | Amgen Inc | BLA | Current |
| 55513-670 | AVSOLA | infliximab-axxq | Amgen Inc | BLA | Current |
| 55513-670 | AVSOLA | infliximab-axxq | Amgen Inc | BLA | Current |
| 55513-670 | AVSOLA | infliximab-axxq | Amgen Inc | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83210 | SUPPL | 2025-08-27 |
| 83209 | SUPPL | 2025-08-27 |
| 83200 | SUPPL | 2025-08-26 |
| 68619 | SUPPL | 2021-09-14 |
| 68567 | SUPPL | 2021-09-10 |
| 61737 | ORIG | 2020-01-30 |
| 61218 | ORIG | 2019-12-10 |
| 61185 | ORIG | 2019-12-06 |
| 61172 | ORIG | 2019-12-06 |
| 63066 | ORIG | 1900-01-01 |