Documents
Application Sponsors
BLA 761068 | ULTRAGENYX PHARM INC | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 10MG/ML | 2 | CRYSVITA | BUROSUMAB-TWZA |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2018-04-17 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 3 | AP | 2019-09-27 | STANDARD |
EFFICACY; Efficacy | SUPPL | 4 | AP | 2019-09-27 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 5 | AP | 2020-06-18 | PRIORITY |
Submissions Property Types
ORIG | 1 | Null | 2 |
SUPPL | 3 | Null | 15 |
SUPPL | 4 | Null | 7 |
SUPPL | 5 | Null | 6 |
CDER Filings
ULTRAGENYX PHARM INC
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[actionDate] => 2020-06-18
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