Skip to content
Application 761261
- Type
- BLA
- Sponsor
- GENZYME CORP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | XENPOZYME | OLIPUDASE ALFA-RPCP | INJECTABLE;INJECTION | 20MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 58468-0050 | XENPOZYME | olipudase alfa-rpcp | Genzyme Corporation | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 80748 | SUPPL | 2024-12-27 |
| 80716 | SUPPL | 2024-12-26 |
| 80715 | SUPPL | 2024-12-26 |
| 76746 | SUPPL | 2023-12-06 |
| 76745 | SUPPL | 2023-12-06 |
| 72071 | ORIG | 2022-09-13 |
| 71994 | ORIG | 2022-09-01 |
| 71988 | ORIG | 2022-09-01 |