FDA.reportPublic FDA data

Application 761231

Type
BLA
Sponsor
AMNEAL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALYMSYSBEVACIZUMAB-MALYINJECTABLE;INJECTION100MG/4ML(25MG/MLNoNo
002ALYMSYSBEVACIZUMAB-MALYINJECTABLE;INJECTION400MG/16ML(25MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70121-1754ALYMSYSbevacizumab-malyAmneal Pharmaceuticals LLCBLACurrent
70121-1754ALYMSYSbevacizumab-malyAmneal Pharmaceuticals LLCBLACurrent
70121-1755ALYMSYSbevacizumab-malyAmneal Pharmaceuticals LLCBLACurrent
70121-1755ALYMSYSbevacizumab-malyAmneal Pharmaceuticals LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71036ORIG2022-05-11
70768ORIG2022-04-15
70759ORIG2022-04-13