BAYER HEALTHCARE PHARMS FDA Approval NDA 213464

NDA 213464

BAYER HEALTHCARE PHARMS

FDA Drug Application

Application #213464

Documents

Label2020-08-06
Letter2020-08-07
Review2020-08-31

Application Sponsors

NDA 213464BAYER HEALTHCARE PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL30MG0LAMPITNIFURTIMOX
002TABLET;ORAL120MG0LAMPITNIFURTIMOX

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2020-08-06PRIORITY

Submissions Property Types

ORIG1Null15

CDER Filings

BAYER HEALTHCARE PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213464
            [companyName] => BAYER HEALTHCARE PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMPIT","activeIngredients":"NIFURTIMOX","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"LAMPIT","activeIngredients":"NIFURTIMOX","strength":"120MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/06\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213464s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213464s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213464Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-08-06
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.