CROSSMEDIKA SA FDA Approval ANDA 213503

ANDA 213503

CROSSMEDIKA SA

FDA Drug Application

Application #213503

Application Sponsors

ANDA 213503CROSSMEDIKA SA

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 10MG BASE0TRANYLCYPROMINE SULFATETRANYLCYPROMINE SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2022-06-27STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

CROSSMEDIKA SA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213503
            [companyName] => CROSSMEDIKA SA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRANYLCYPROMINE SULFATE","activeIngredients":"TRANYLCYPROMINE SULFATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/27\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-27
        )

)

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