FDA.reportPublic FDA data

Application 125469

Type
BLA
Sponsor
ELI LILLY AND CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRULICITYDULAGLUTIDEINJECTABLE;INJECTION0.75MG/0.5MLNoNo
002TRULICITYDULAGLUTIDEINJECTABLE;INJECTION1.5MG/0.5MLYesNo
003TRULICITYDULAGLUTIDEINJECTABLE;INJECTION3MG/0.5MLNoNo
004TRULICITYDULAGLUTIDEINJECTABLE;INJECTION4.5MG/0.5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-1433TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1433TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1433TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1433TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1433TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1433TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1433TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1433TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1433TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1433TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1433TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1433TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1433TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1434TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1434TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1434TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1434TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1434TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1434TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1434TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1434TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1434TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1434TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1434TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1434TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-1434TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-2236TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-2236TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-2236TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-2236TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-2236TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-2236TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-2236TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-2236TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-2236TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-2236TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-3182TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-3182TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-3182TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-3182TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-3182TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-3182TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-3182TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-3182TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-3182TrulicityDulaglutideEli Lilly and CompanyBLACurrent
0002-3182TrulicityDulaglutideEli Lilly and CompanyBLACurrent
50090-3483TrulicityDulaglutideA-S Medication SolutionsBLACurrent
50090-3483TrulicityDulaglutideA-S Medication SolutionsBLACurrent
50090-3483TrulicityDulaglutideA-S Medication SolutionsBLACurrent
50090-3483TrulicityDulaglutideA-S Medication SolutionsBLACurrent
50090-3484TrulicityDulaglutideA-S Medication SolutionsBLACurrent
50090-3484TrulicityDulaglutideA-S Medication SolutionsBLACurrent
50090-3484TrulicityDulaglutideA-S Medication SolutionsBLACurrent
50090-3484TrulicityDulaglutideA-S Medication SolutionsBLACurrent
50090-3484TrulicityDulaglutideA-S Medication SolutionsBLACurrent
50090-5467TrulicityDulaglutideA-S Medication SolutionsBLACurrent
50090-5467TrulicityDulaglutideA-S Medication SolutionsBLACurrent
50090-5467TrulicityDulaglutideA-S Medication SolutionsBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85385SUPPL 2026-03-18
85373SUPPL 2026-03-16
85386SUPPL 2026-03-12
82377SUPPL 2025-06-02
82344SUPPL 2025-05-29
80121SUPPL 2024-11-05
80116SUPPL 2024-11-04
80115SUPPL 2024-11-04
72661SUPPL2022-11-21
72660SUPPL2022-11-21
72650SUPPL2022-11-18
71326SUPPL2022-06-15
71325SUPPL2022-06-15
71324SUPPL2022-06-15
71278SUPPL2022-06-13
71277SUPPL2022-06-13
68867SUPPL2021-10-04
68850SUPPL2021-10-01
68849SUPPL2021-10-01
64530SUPPL2020-09-08
64490SUPPL2020-09-04
61954SUPPL2020-02-25
61949SUPPL2020-02-24
61945SUPPL2020-02-24
57250SUPPL2019-01-18
57231SUPPL2019-01-16
57230SUPPL2019-01-16
55923SUPPL2018-10-15
55738SUPPL2018-10-01
54880SUPPL2018-07-13
54824SUPPL2018-07-06
50749SUPPL2017-12-18
49232SUPPL2017-08-04
49231SUPPL2017-08-04
49214SUPPL2017-08-02
49213SUPPL2017-08-02
47052SUPPL2017-01-31
47051SUPPL2017-01-31
47030SUPPL2017-01-27
47029SUPPL2017-01-27
9762SUPPL2015-07-28
18917ORIG2015-04-01
31973SUPPL2015-03-11
31974SUPPL2014-12-24
44809ORIG2014-10-27
22812ORIG2014-10-27
9761ORIG2014-09-19