Application Sponsors
NDA 020259 | GLAXOSMITHKLINE LLC | |
Marketing Status
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001 | TABLET;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | MEPRON | ATOVAQUONE |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
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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":"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
)
)