FDA.reportPublic FDA data

Application 761231

Type
BLA
Sponsor
AMNEAL PHARMS LLC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761231Alymsysbevacizumab-maly351(k) BiosimilarRx2026-07-01

Application Products#

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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALYMSYSBEVACIZUMAB-MALYAmneal Pharmaceuticals LLC6b4040a2-a5c5-4ff0-ab45-935d7e49cf782026-03-23Warnings, Adverse reactionsExact identifier
application number: BLA761231
ndc (product): 70121-1754
ndc (product): 70121-1755
ALYMSYSBEVACIZUMAB-MALYValorum Biologics, LLC42b4f96e-1f70-2126-e063-6294a90a93e32026-01-27Warnings, Adverse reactionsExact identifier
application number: BLA761231

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
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