FDA.reportPublic FDA data

Application 125477

Type
BLA
Sponsor
ELI LILLY AND CO

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125477Cyramzaramucirumab351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYRAMZARAMUCIRUMABINJECTABLE;INJECTION100MG/10MLNoNo
002CYRAMZARAMUCIRUMABINJECTABLE;INJECTION500MG/50MLNoNo

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
CYRAMZARAMUCIRUMABEli Lilly and Companyc6080942-dee6-423e-b688-1272c2ae90d42026-06-09Warnings, Adverse reactionsExact identifier
application number: BLA125477
ndc (product): 0002-7669
ndc (product): 0002-7678

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-7669CYRAMZAramucirumabEli Lilly and CompanyBLACurrent
0002-7669CYRAMZAramucirumabEli Lilly and CompanyBLACurrent
0002-7669CYRAMZAramucirumabEli Lilly and CompanyBLACurrent
0002-7669CYRAMZAramucirumabEli Lilly and CompanyBLACurrent
0002-7669CYRAMZAramucirumabEli Lilly and CompanyBLACurrent
0002-7669CYRAMZAramucirumabEli Lilly and CompanyBLACurrent
0002-7669CYRAMZAramucirumabEli Lilly and CompanyBLACurrent
0002-7669CYRAMZAramucirumabEli Lilly and CompanyBLACurrent
0002-7669CYRAMZAramucirumabEli Lilly and CompanyBLACurrent
0002-7669CYRAMZAramucirumabEli Lilly and CompanyBLACurrent
0002-7669CYRAMZAramucirumabEli Lilly and CompanyBLACurrent
0002-7678CYRAMZAramucirumabEli Lilly and CompanyBLACurrent
0002-7678CYRAMZAramucirumabEli Lilly and CompanyBLACurrent
0002-7678CYRAMZAramucirumabEli Lilly and CompanyBLACurrent
0002-7678CYRAMZAramucirumabEli Lilly and CompanyBLACurrent
0002-7678CYRAMZAramucirumabEli Lilly and CompanyBLACurrent
0002-7678CYRAMZAramucirumabEli Lilly and CompanyBLACurrent
0002-7678CYRAMZAramucirumabEli Lilly and CompanyBLACurrent
0002-7678CYRAMZAramucirumabEli Lilly and CompanyBLACurrent
0002-7678CYRAMZAramucirumabEli Lilly and CompanyBLACurrent
0002-7678CYRAMZAramucirumabEli Lilly and CompanyBLACurrent
0002-7678CYRAMZAramucirumabEli Lilly and CompanyBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83166SUPPL 2025-08-21
83158SUPPL 2025-08-20
81906SUPPL 2025-04-09
81833SUPPL 2025-04-08
81170SUPPL 2025-02-07
80976SUPPL 2025-02-05
70588SUPPL2022-03-23
70585SUPPL2022-03-23
67840SUPPL2021-06-17
67831SUPPL2021-06-16
63826SUPPL2020-07-08
63817SUPPL2020-07-07
63455SUPPL2020-06-09
63380SUPPL2020-06-02
61938SUPPL2020-02-21
61931SUPPL2020-02-21
60802SUPPL2019-11-08
59547SUPPL2019-08-02
59535SUPPL2019-08-01
58673SUPPL2019-05-14
56578SUPPL2018-11-27
55316SUPPL2018-08-24
55176SUPPL2018-08-15
9767SUPPL2015-04-27
18920SUPPL2015-04-24
9766SUPPL2014-12-15
39975SUPPL2014-12-12
31976SUPPL2014-11-06
39974SUPPL2014-11-05
43331ORIG2014-05-16
24374ORIG2014-05-16
31975ORIG2014-04-22
18919ORIG2014-04-21