HETERO LABS LTD V FDA Approval ANDA 204397

ANDA 204397

HETERO LABS LTD V

FDA Drug Application

Application #204397

Application Sponsors

ANDA 204397HETERO LABS LTD V

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL1MG0TOLTERODINE TARTRATETOLTERODINE TARTRATE
002TABLET;ORAL2MG0TOLTERODINE TARTRATETOLTERODINE TARTRATE

FDA Submissions

UNKNOWN; ORIG1AP2021-08-02

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

HETERO LABS LTD V
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204397
            [companyName] => HETERO LABS LTD V
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOLTERODINE TARTRATE","activeIngredients":"TOLTERODINE TARTRATE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TOLTERODINE TARTRATE","activeIngredients":"TOLTERODINE TARTRATE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/02\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-02
        )

)

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