Application 761165
- Type
- BLA
- Sponsor
- COHERUS BIOSCIENCES INC
Application Products#
Product, Drug, Ingredient table| 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 |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 78543 | SUPPL | 2024-05-22 |
| 78525 | SUPPL | 2024-05-22 |
| 71872 | ORIG | 2022-08-23 |
| 71701 | ORIG | 2022-08-03 |
| 71698 | ORIG | 2022-08-02 |