Documents
Application Sponsors
| NDA 207924 | ELI LILLY AND CO | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 2MG | 1 | OLUMIANT | BARICITINIB |
| 002 | TABLET;ORAL | 1MG | 1 | OLUMIANT | BARICITINIB |
| 003 | TABLET;ORAL | 4MG | 1 | OLUMIANT | BARICITINIB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2018-05-31 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2020-07-08 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2021-12-02 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2022-05-10 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2022-06-13 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 15 |
CDER Filings
ELI LILLY AND CO
cder:Array
(
[0] => Array
(
[ApplNo] => 207924
[companyName] => ELI LILLY AND CO
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/207924s002lbl.pdf#page=18"]
[products] => [{"drugName":"OLUMIANT","activeIngredients":"BARICITINIB","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"OLUMIANT","activeIngredients":"BARICITINIB","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"07\/08\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207924s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/2019","submission":"SUPPL-1","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207924s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/31\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207924Orig1s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"05\/31\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207924Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207924Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/207924Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"07\/08\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207924s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/207924Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"10\/08\/2019","submission":"SUPPL-1","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207924s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/207924Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-07-08
)
)