Application 761052
- Type
- BLA
- Sponsor
- BIOMARIN PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BRINEURA | CERLIPONASE ALFA | INJECTABLE;INJECTION | 30MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68135-811 | Brineura | cerliponase alfa | BioMarin Pharmaceutical Inc. | BLA | Current |
| 68135-811 | Brineura | cerliponase alfa | BioMarin Pharmaceutical Inc. | BLA | Current |
| 68135-811 | Brineura | cerliponase alfa | BioMarin Pharmaceutical Inc. | BLA | Current |
| 68135-811 | Brineura | cerliponase alfa | BioMarin Pharmaceutical Inc. | BLA | Current |
| 68135-811 | Brineura | cerliponase alfa | BioMarin Pharmaceutical Inc. | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79223 | SUPPL | 2024-07-29 |
| 79208 | SUPPL | 2024-07-25 |
| 79080 | SUPPL | 2024-07-15 |
| 79048 | SUPPL | 2024-07-11 |
| 62373 | SUPPL | 2020-03-31 |
| 62359 | SUPPL | 2020-03-30 |
| 61217 | SUPPL | 2019-12-10 |
| 61193 | SUPPL | 2019-12-09 |
| 56844 | SUPPL | 2018-12-20 |
| 56712 | SUPPL | 2018-12-12 |
| 48669 | ORIG | 2017-06-07 |
| 48156 | ORIG | 2017-04-28 |
| 48155 | ORIG | 2017-04-28 |