ACCORD HLTHCARE FDA Approval ANDA 213342

ANDA 213342

ACCORD HLTHCARE

FDA Drug Application

Application #213342

Application Sponsors

ANDA 213342ACCORD HLTHCARE

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL200MG0HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATE
002TABLET;ORAL100MG0HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATE
003TABLET;ORAL300MG0HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATE
004TABLET;ORAL400MG0HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2020-04-07STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

ACCORD HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213342
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYCHLOROQUINE SULFATE","activeIngredients":"HYDROXYCHLOROQUINE SULFATE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/07\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-07
        )

)

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