FDA.reportPublic FDA data

Application 208716

Type
NDA
Sponsor
ELI LILLY AND CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VERZENIOABEMACICLIBTABLET;ORAL50MGYesNo
002VERZENIOABEMACICLIBTABLET;ORAL100MGYesNo
003VERZENIOABEMACICLIBTABLET;ORAL150MGYesNo
004VERZENIOABEMACICLIBTABLET;ORAL200MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-4483VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-4483VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-4483VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-4483VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-4483VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-4483VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-4815VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-4815VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-4815VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-4815VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-4815VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-4815VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-5337VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-5337VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-5337VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-5337VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-5337VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-5337VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-6216VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-6216VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-6216VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-6216VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-6216VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-6216VerzenioabemaciclibEli Lilly and CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81385SUPPL 2025-03-03
81381SUPPL 2025-02-28
80215SUPPL 2024-11-14
80213SUPPL 2024-11-14
73682SUPPL 2023-03-06
73681SUPPL 2023-03-06
73674SUPPL 2023-03-03
73673SUPPL 2023-03-03
68982SUPPL2021-10-14
68981SUPPL2021-10-14
68980SUPPL2021-10-14
68967SUPPL2021-10-13
68966SUPPL2021-10-13
68965SUPPL2021-10-13
62406SUPPL2020-04-01
62394SUPPL2020-03-31
59972SUPPL2019-09-11
59957SUPPL2019-09-09
55257SUPPL2018-08-21
55214SUPPL2018-08-20
50236ORIG2017-10-31
49891ORIG2017-09-28
49872ORIG2017-09-28