Application 761179

Type
BLA
Sponsor
JAZZ PHARMS

Application Products#

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

NDC Listings For This Application#

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