Application 761197
- Type
- BLA
- Sponsor
- GENENTECH INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761197 | Susvimo | ranibizumab | 351(a) | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SUSVIMO | RANOBIZUMAB | INJECTABLE;INJECTION | 100MG/ML | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Susvimo | RANIBIZUMAB | Genentech, Inc. | 9c6d9e2a-9a77-4d11-b692-de87cfde3444 | 2025-11-21 | Boxed warning, Warnings, Adverse reactions | BLA761197 50242-078 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
Documents#
| 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 |