Skip to content
Application 761149
- Type
- BLA
- Sponsor
- GENENTECH
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ENSPRYNG | SATRALIZUMAB | INJECTABLE;INJECTION | 120MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50242-007 | Enspryng | Satralizumab | Genentech Inc. | BLA | Current |
| 50242-007 | Enspryng | Satralizumab | Genentech Inc. | BLA | Current |
| 50242-007 | Enspryng | Satralizumab | Genentech Inc. | BLA | Current |
| 50242-007 | Enspryng | Satralizumab | Genentech Inc. | BLA | Current |
| 50242-007 | Enspryng | Satralizumab | Genentech Inc. | BLA | Current |
| 50242-007 | Enspryng | Satralizumab | Genentech Inc. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 72085 | SUPPL | 2022-09-15 |
| 72080 | SUPPL | 2022-09-15 |
| 72079 | SUPPL | 2022-09-15 |
| 67440 | SUPPL | 2021-05-07 |
| 67398 | SUPPL | 2021-05-04 |
| 64565 | ORIG | 2020-09-11 |
| 64288 | ORIG | 2020-08-17 |
| 64283 | ORIG | 2020-08-17 |