NDA 210498

ARRAY BIOPHARMA INC

FDA Drug Application

Application #210498

Documents

• Label: 2019-01-23
• Review: 2018-08-22
• Letter: 2019-02-13
• Label: 2019-09-23
• Letter: 2019-09-23

Application Sponsors

NDA 210498

ARRAY BIOPHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

15MG

1

MEKTOVI

BINIMETINIB

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination

ORIG

1

AP

2018-06-27

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

ARRAY BIOPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210498
            [companyName] => ARRAY BIOPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEKTOVI","activeIngredients":"BINIMETINIB","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/23\/2019","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210498s001lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210498lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/27\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity and Type 4 - New Combination","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210498lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210498Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210498Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/23\/2019","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210498s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210498Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-01-23
        )

)