Application 761194

Type
BLA
Sponsor
GENZYME CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEXVIAZYMEAVALGLUCOSIDASE ALFA-NGPTINJECTABLE;INJECTION100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58468-0426Nexviazymeavalglucosidase alfaGenzyme CorporationBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75509SUPPL 2023-09-18
75501SUPPL 2023-09-18
68549ORIG2021-09-07
68329ORIG2021-08-10
68317ORIG2021-08-09