MIRATI THERAPEUTICS, INC FDA Approval NDA 216340

NDA 216340

MIRATI THERAPEUTICS, INC

FDA Drug Application

Application #216340

Documents

Label2022-12-12
Letter2022-12-13
Review2023-01-11

Application Sponsors

NDA 216340MIRATI THERAPEUTICS, INC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL200mg0KRAZATI (ADAGRASIB)ADAGRASIB

FDA Submissions

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

Submissions Property Types

ORIG1Null2

CDER Filings

MIRATI THERAPEUTICS, INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216340
            [companyName] => MIRATI THERAPEUTICS, INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"KRAZATI (ADAGRASIB)","activeIngredients":"ADAGRASIB","strength":"200mg","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/12\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216340Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/12\/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\\\/216340Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/216340Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-12-12
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.