FDA.reportPublic FDA data

Application 761068

Type
BLA
Sponsor
ULTRAGENYX PHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CRYSVITABUROSUMAB-TWZAINJECTABLE;INJECTION10MG/MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69794-102CRYSVITABurosumabUltragenyx Pharmaceutical Inc.BLACurrent
69794-102CRYSVITABurosumabUltragenyx Pharmaceutical Inc.BLACurrent
69794-102CRYSVITABurosumabUltragenyx Pharmaceutical Inc.BLACurrent
69794-102CRYSVITABurosumabUltragenyx Pharmaceutical Inc.BLACurrent
69794-102CRYSVITABurosumabUltragenyx Pharmaceutical Inc.BLACurrent
69794-203CRYSVITABurosumabUltragenyx Pharmaceutical Inc.BLACurrent
69794-203CRYSVITABurosumabUltragenyx Pharmaceutical Inc.BLACurrent
69794-203CRYSVITABurosumabUltragenyx Pharmaceutical Inc.BLACurrent
69794-203CRYSVITABurosumabUltragenyx Pharmaceutical Inc.BLACurrent
69794-203CRYSVITABurosumabUltragenyx Pharmaceutical Inc.BLACurrent
69794-304CRYSVITABurosumabUltragenyx Pharmaceutical Inc.BLACurrent
69794-304CRYSVITABurosumabUltragenyx Pharmaceutical Inc.BLACurrent
69794-304CRYSVITABurosumabUltragenyx Pharmaceutical Inc.BLACurrent
69794-304CRYSVITABurosumabUltragenyx Pharmaceutical Inc.BLACurrent
69794-304CRYSVITABurosumabUltragenyx Pharmaceutical Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85760SUPPL 2026-04-27
85751SUPPL 2026-04-24
83258SUPPL 2025-09-02
83239SUPPL 2025-08-29
63651SUPPL2020-06-22
63628SUPPL2020-06-19
60253SUPPL2019-10-07
60184SUPPL2019-10-01
60170SUPPL2019-10-01
60163SUPPL2019-09-30
54189ORIG2018-05-15
53710ORIG2018-04-17
53709ORIG2018-04-17