SHANDONG FDA Approval ANDA 214115

ANDA 214115

SHANDONG

FDA Drug Application

Application #214115

Application Sponsors

ANDA 214115SHANDONG

Marketing Status

Prescription001

Application Products

001TABLET, EXTENDED RELEASE;ORAL120MG0ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE

FDA Submissions

UNKNOWN; ORIG1AP2022-04-29STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

SHANDONG
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214115
            [companyName] => SHANDONG
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSORBIDE MONONITRATE","activeIngredients":"ISOSORBIDE MONONITRATE","strength":"120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/29\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-29
        )

)

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