Application 761047
- Type
- BLA
- Sponsor
- ULTRAGENYX PHARM INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MEPSEVII | VESTRONIDASE ALFA-VJBK | INJECTABLE;INJECTION | 10MG/5ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69794-001 | MEPSEVII | vestronidase alfa | Ultragenyx Pharmaceutical Inc. | BLA | Current |
| 69794-001 | MEPSEVII | vestronidase alfa | Ultragenyx Pharmaceutical Inc. | BLA | Current |
| 69794-001 | MEPSEVII | vestronidase alfa | Ultragenyx Pharmaceutical Inc. | BLA | Current |
| 69794-001 | MEPSEVII | vestronidase alfa | Ultragenyx Pharmaceutical Inc. | BLA | Current |
| 69794-001 | MEPSEVII | vestronidase alfa | Ultragenyx Pharmaceutical Inc. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 65769 | SUPPL | 2020-12-28 |
| 65760 | SUPPL | 2020-12-28 |
| 61216 | SUPPL | 2019-12-10 |
| 61192 | SUPPL | 2019-12-09 |
| 50930 | ORIG | 2017-12-27 |
| 50521 | ORIG | 2017-11-29 |
| 50419 | ORIG | 2017-11-15 |