ELI LILLY AND CO FDA Approval NDA 207924

NDA 207924

ELI LILLY AND CO

FDA Drug Application

Application #207924

Documents

Label2018-06-01
Letter2018-06-01
Review2018-07-05
Letter2019-10-10
Label2019-10-10
Medication Guide2019-10-10
Letter2020-07-09
Label2020-07-09
Medication Guide2020-07-09
Label2021-12-07
Letter2021-12-07
Label2022-05-10
Medication Guide2022-05-10
Letter2022-05-11
Letter2022-06-14
Label2022-06-15

Application Sponsors

NDA 207924ELI LILLY AND CO

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL2MG1OLUMIANTBARICITINIB
002TABLET;ORAL1MG1OLUMIANTBARICITINIB
003TABLET;ORAL4MG1OLUMIANTBARICITINIB

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2018-05-31STANDARD
LABELING; LabelingSUPPL2AP2020-07-08STANDARD
LABELING; LabelingSUPPL4AP2021-12-02STANDARD
EFFICACY; EfficacySUPPL6AP2022-05-10PRIORITY
EFFICACY; EfficacySUPPL7AP2022-06-13PRIORITY

Submissions Property Types

ORIG1Null7
SUPPL2Null7
SUPPL4Null15
SUPPL6Null15
SUPPL7Null15

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
        )

)

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