BRISTOL-MYERS SQUIBB FDA Approval NDA 214958

NDA 214958

BRISTOL-MYERS SQUIBB

FDA Drug Application

Application #214958

Documents

Letter2022-09-12
Label2022-09-13
Medication Guide2022-09-13

Application Sponsors

NDA 214958BRISTOL-MYERS SQUIBB

Marketing Status

Prescription001

Application Products

001TABLET; ORAL6MG (3)0SOTYKTUDEUCRAVACITINIB

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2022-09-09STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

BRISTOL-MYERS SQUIBB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214958
            [companyName] => BRISTOL-MYERS SQUIBB
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/214958s000lbl.pdf#page=19"]
            [products] => [{"drugName":"SOTYKTU","activeIngredients":"DEUCRAVACITINIB","strength":"6MG (3)","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/09\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/214958s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/09\/2022","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\\\/2022\\\/214958s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/214958Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-09-09
        )

)

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