FDA.reportPublic FDA data

Application 761179

Type
BLA
Sponsor
JAZZ PHARMS

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761179Rylazeasparaginase erwinia chrysanthemi (recombinant)-rywn351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RYLAZEASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWNINJECTABLE;INTRAMUSCULAR10MG/0.5MLNoNo

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
RylazeASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWNJazz Pharmaceuticals, Inc.857e53aa-1098-4dad-b654-0276cdd43e032025-07-01Warnings, Adverse reactionsExact identifier
application number: BLA761179
ndc (product): 68727-900

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68727-900Rylazeasparaginase erwinia chrysanthemi (recombinant)-rywnJazz Pharmaceuticals, Inc.BLACurrent
68727-900Rylazeasparaginase erwinia chrysanthemi (recombinant)-rywnJazz Pharmaceuticals, Inc.BLACurrent
68727-900Rylazeasparaginase erwinia chrysanthemi (recombinant)-rywnJazz Pharmaceuticals, Inc.BLACurrent
68727-900Rylazeasparaginase erwinia chrysanthemi (recombinant)-rywnJazz Pharmaceuticals, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78150SUPPL 2024-04-16
78146SUPPL 2024-04-16
72694SUPPL2022-11-24
72667SUPPL2022-11-22
68223ORIG2021-07-29
68006ORIG2021-07-01
67996ORIG2021-07-01