AMTA FDA Approval ANDA 214376

ANDA 214376

AMTA

FDA Drug Application

Application #214376

Application Sponsors

ANDA 214376AMTA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, DELAYED RELEASE;ORAL180MG0MYCOPHENOLIC ACIDMYCOPHENOLIC ACID
002TABLET, DELAYED RELEASE;ORAL360MG0MYCOPHENOLIC ACIDMYCOPHENOLIC ACID

FDA Submissions

UNKNOWN; ORIG1AP2021-02-10STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

AMTA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214376
            [companyName] => AMTA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOPHENOLIC ACID","activeIngredients":"MYCOPHENOLIC ACID","strength":"180MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MYCOPHENOLIC ACID","activeIngredients":"MYCOPHENOLIC ACID","strength":"360MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/10\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-10
        )

)

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