AMTA FDA Approval ANDA 213858

ANDA 213858

AMTA

FDA Drug Application

Application #213858

Application Sponsors

ANDA 213858AMTA

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE, EXTENDED RELEASE;ORAL2MG0TOLTERODINE TARTRATETOLTERODINE TARTRATE
002CAPSULE, EXTENDED RELEASE;ORAL4MG0TOLTERODINE TARTRATETOLTERODINE TARTRATE

FDA Submissions

UNKNOWN; ORIG1AP2021-02-02STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

AMTA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213858
            [companyName] => AMTA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOLTERODINE TARTRATE","activeIngredients":"TOLTERODINE TARTRATE","strength":"2MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TOLTERODINE TARTRATE","activeIngredients":"TOLTERODINE TARTRATE","strength":"4MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/02\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-02
        )

)

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