NDA 204369

BAYER HEALTHCARE PHARMS

FDA Drug Application

Application #204369

Documents

• Letter: 2013-02-26
• Review: 2014-01-07
• Summary Review: 2014-01-07
• Label: 2013-02-25

Application Sponsors

NDA 204369

BAYER HEALTHCARE PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET; ORAL

40MG

2

STIVARGA

REGORAFENIB

FDA Submissions

TYPE 9; Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval

ORIG

1

AP

2013-02-25

PRIORITY

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

TBD

CDER Filings

BAYER HEALTHCARE PHARMS

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(
    [0] => Array
        (
            [ApplNo] => 204369
            [companyName] => BAYER HEALTHCARE PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"STIVARGA","activeIngredients":"REGORAFENIB","strength":"40MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"02\/25\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204369lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/25\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204369lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/204369Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204369Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204369Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2013-02-25
        )

)