ASPEN GLOBAL INC FDA Approval ANDA 204713

ANDA 204713

ASPEN GLOBAL INC

FDA Drug Application

Application #204713

Application Sponsors

ANDA 204713ASPEN GLOBAL INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL0.5MG0BENZTROPINE MESYLATEBENZTROPINE MESYLATE
002TABLET;ORAL1MG0BENZTROPINE MESYLATEBENZTROPINE MESYLATE
003TABLET;ORAL2MG0BENZTROPINE MESYLATEBENZTROPINE MESYLATE

FDA Submissions

UNKNOWN; ORIG1AP2015-04-14

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA
002PrescriptionAA
003PrescriptionAA

CDER Filings

ASPEN GLOBAL INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204713
            [companyName] => ASPEN GLOBAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENZTROPINE MESYLATE","activeIngredients":"BENZTROPINE MESYLATE","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"BENZTROPINE MESYLATE","activeIngredients":"BENZTROPINE MESYLATE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"BENZTROPINE MESYLATE","activeIngredients":"BENZTROPINE MESYLATE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/14\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-04-14
        )

)

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