AJANTA PHARMA LTD FDA Approval ANDA 213397

ANDA 213397

AJANTA PHARMA LTD

FDA Drug Application

Application #213397

Application Sponsors

ANDA 213397AJANTA PHARMA LTD

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2020-05-19STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

AJANTA PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213397
            [companyName] => AJANTA PHARMA LTD
            [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":"05\/19\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-19
        )

)

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