MSN FDA Approval ANDA 212818

ANDA 212818

MSN

FDA Drug Application

Application #212818

Application Sponsors

ANDA 212818MSN

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 60MG BASE0TOREMIFENE CITRATETOREMIFENE CITRATE

FDA Submissions

UNKNOWN; ORIG1AP2020-08-18STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

MSN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212818
            [companyName] => MSN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOREMIFENE CITRATE","activeIngredients":"TOREMIFENE CITRATE","strength":"EQ 60MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/18\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-18
        )

)

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