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Application 761197
- Type
- BLA
- Sponsor
- GENENTECH INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SUSVIMO | RANOBIZUMAB | INJECTABLE;INJECTION | 100MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50242-078 | Susvimo | Ranibizumab | Genentech, Inc. | BLA | Current |
| 50242-078 | Susvimo | Ranibizumab | Genentech, Inc. | BLA | Current |
| 50242-078 | Susvimo | Ranibizumab | Genentech, Inc. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83312 | SUPPL | 2025-09-09 |
| 83311 | SUPPL | 2025-09-09 |
| 83305 | SUPPL | 2025-09-08 |
| 82452 | SUPPL | 2025-06-03 |
| 82304 | SUPPL | 2025-05-23 |
| 81171 | SUPPL | 2025-02-07 |
| 81075 | SUPPL | 2025-02-06 |
| 72128 | ORIG | 2022-09-21 |
| 70795 | SUPPL | 2022-04-20 |
| 70789 | SUPPL | 2022-04-19 |
| 69107 | ORIG | 2021-10-25 |
| 69106 | ORIG | 2021-10-25 |