NDA 020259

GLAXOSMITHKLINE LLC

FDA Drug Application

Application #020259

Application Sponsors

NDA 020259

GLAXOSMITHKLINE LLC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

MEPRON

ATOVAQUONE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

1992-11-25

PRIORITY

Submissions Property Types

ORIG

1

Null

39

CDER Filings

GLAXOSMITHKLINE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20259
            [companyName] => GLAXOSMITHKLINE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEPRON","activeIngredients":"ATOVAQUONE","strength":"250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MEPRON","submission":"ATOVAQUONE","actionType":"250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)