Application 761149
- Type
- BLA
- Sponsor
- GENENTECH
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761149 | Enspryng | satralizumab-mwge | 351(a) | Rx | 2026-10-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ENSPRYNG | SATRALIZUMAB | INJECTABLE;INJECTION | 120MG/ML | No | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 6 matching rows.
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 |