Application 761047
- Type
- BLA
- Sponsor
- ULTRAGENYX PHARM INC
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761047 | Mepsevii | vestronidase alfa-vjbk | 351(a) | Rx | 2026-10-01 |
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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 5 matching rows.
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 |