FDA.reportPublic FDA data

Application 761068

Type
BLA
Sponsor
ULTRAGENYX PHARM INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761068Crysvitaburosumab-twza351(a)Rx2026-07-01

Application Products#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CRYSVITABUROSUMABKyowa Kirin, Inc.102f96a0-6e3a-4fc1-b204-34d604683af62026-04-22Warnings, Adverse reactionsExact identifier
application number: BLA761068

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

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