Skip to contentApplication 761074
- Type
- BLA
- Sponsor
- MYLAN GMBH
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OGIVRI | TRASTUZUMAB-DKST | INJECTABLE;INJECTION | 420MG/VIAL | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67457-845 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
| 67457-845 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
| 67457-847 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
| 67457-847 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
| 67457-847 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
| 67457-847 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
| 67457-847 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
| 67457-847 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
| 67457-847 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
| 67457-847 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
| 67457-847 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
| 67457-847 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
| 67457-991 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
| 67457-991 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
| 67457-991 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
| 67457-991 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
| 67457-991 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
| 67457-991 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
| 67457-991 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
| 67457-991 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
| 67457-991 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
| 67457-991 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
| 67457-991 | OGIVRI | trastuzumab | Mylan Institutional LLC | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 80217 | SUPPL | 2024-11-14 |
| 80210 | SUPPL | 2024-11-14 |
| 75669 | SUPPL | 2023-10-03 |
| 75666 | SUPPL | 2023-10-03 |
| 59232 | SUPPL | 2019-07-03 |
| 58367 | SUPPL | 2019-04-23 |
| 50582 | ORIG | 2019-01-30 |
| 56585 | ORIG | 2018-11-29 |
| 50536 | ORIG | 2017-12-01 |