Application 207924

Type
NDA
Sponsor
ELI LILLY AND CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLUMIANTBARICITINIBTABLET;ORAL2MGYesYes
002OLUMIANTBARICITINIBTABLET;ORAL1MGYesNo
003OLUMIANTBARICITINIBTABLET;ORAL4MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-4182OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4182OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4182OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4182OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4182OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4182OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4182OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4182OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4182OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4182OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4182OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4182OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4479OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4479OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4732OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4732OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4732OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4732OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4732OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4732OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4732OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4732OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4732OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4732OlumiantbaricitinibEli Lilly and CompanyNDACurrent
0002-4732OlumiantbaricitinibEli Lilly and CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71331SUPPL2022-06-15
71300SUPPL2022-06-14
71035SUPPL2022-05-11
71034SUPPL2022-05-10
71033SUPPL2022-05-10
69501SUPPL2021-12-07
69485SUPPL2021-12-07
63838SUPPL2020-07-09
63837SUPPL2020-07-09
63834SUPPL2020-07-09
60520SUPPL2019-10-10
60519SUPPL2019-10-10
60506SUPPL2019-10-10
54749ORIG2018-07-05
54403ORIG2018-06-01
54401ORIG2018-06-01