FDA.reportPublic FDA data

Application 125477

Type
BLA
Sponsor
ELI LILLY AND CO

Application Products#

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

NDC Listings For This Application#

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