FORMA THERAPEUTICS, INC FDA Approval NDA 215814

NDA 215814

FORMA THERAPEUTICS, INC

FDA Drug Application

Application #215814

Documents

Letter2022-12-02
Label2022-12-08
Medication Guide2022-12-08
Review2022-12-23

Application Sponsors

NDA 215814FORMA THERAPEUTICS, INC

Marketing Status

Prescription001

Application Products

001CAPSULE; ORAL150MG0REZLIDHIAOLUTASIDENIB

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2022-12-01STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

FORMA THERAPEUTICS, INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215814
            [companyName] => FORMA THERAPEUTICS, INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"REZLIDHIA","activeIngredients":"OLUTASIDENIB","strength":"150MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/01\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215814Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-01
        )

)

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