NDA 210795

GLAXOSMITHKLINE

FDA Drug Application

Application #210795

Documents

• Label: 2018-07-20
• Letter: 2018-07-23
• Review: 2018-08-24
• Label: 2020-11-16
• Letter: 2020-11-17

Application Sponsors

NDA 210795

GLAXOSMITHKLINE

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 150MG BASE

1

KRINTAFEL

TAFENOQUINE SUCCINATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2018-07-20

PRIORITY

Submissions Property Types

ORIG

1

Null

6

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210795
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"KRINTAFEL","activeIngredients":"TAFENOQUINE SUCCINATE","strength":"EQ 150MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/20\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210795s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/20\/2018","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\\\/2018\\\/210795s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210795Orig1s000Ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210795Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-07-20
        )

)