Application 761165
- Type
- BLA
- Sponsor
- COHERUS BIOSCIENCES INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761165 | Cimerli | ranibizumab-eqrn | 351(k) Interchangeable | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CIMERLI | RANIBIZUMAB-EQRN | INJECTABLE;INJECTION | 0.3MG(6MG/ML) | No | No |
| 002 | CIMERLI | RANIBIZUMAB-EQRN | INJECTABLE;INJECTION | 0.5MG(10MG/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 |
|---|---|---|---|---|---|---|
| CIMERLI | RANIBIZUMAB-EQRN | Coherus BioSciences Inc | e0e23118-1490-a554-e053-2995a90ab90c | 2025-05-07 | Warnings, Adverse reactions | BLA761165 70114-440 70114-441 |
| CIMERLI | RANIBIZUMAB-EQRN | Sandoz Inc | 4b383d74-4830-4587-95f7-c32a39268df7 | 2024-06-17 | Warnings, Adverse reactions | BLA761165 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70114-440 | CIMERLI | ranibizumab-eqrn | Coherus BioSciences Inc | BLA | Current |
| 70114-440 | CIMERLI | ranibizumab-eqrn | COHERUS BioSciences, Inc. | BLA | Current |
| 70114-441 | CIMERLI | ranibizumab-eqrn | Coherus BioSciences Inc | BLA | Current |
| 70114-441 | CIMERLI | ranibizumab-eqrn | COHERUS BioSciences, Inc. | BLA | Current |