NDA 216340

MIRATI THERAPEUTICS, INC

FDA Drug Application

Application #216340

Documents

• Label: 2022-12-12
• Letter: 2022-12-13
• Review: 2023-01-11

Application Sponsors

NDA 216340

MIRATI THERAPEUTICS, INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

200mg

0

KRAZATI (ADAGRASIB)

ADAGRASIB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2022-12-12

STANDARD

Submissions Property Types

ORIG

1

Null

2

CDER Filings

MIRATI THERAPEUTICS, INC

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(
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        (
            [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
        )

)