TEVA PHARMS FDA Approval ANDA 215506

ANDA 215506

TEVA PHARMS

FDA Drug Application

Application #215506

Application Sponsors

ANDA 215506TEVA PHARMS

Marketing Status

Prescription001

Application Products

001TABLET;ORAL25MG0PYRIMETHAMINEPYRIMETHAMINE

FDA Submissions

UNKNOWN; ORIG1AP2021-08-13STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

TEVA PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215506
            [companyName] => TEVA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PYRIMETHAMINE","activeIngredients":"PYRIMETHAMINE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/13\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-13
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.