ACCORD HLTHCARE INC FDA Approval NDA 214121

NDA 214121

ACCORD HLTHCARE INC

FDA Drug Application

Application #214121

Documents

Letter2020-08-25

Application Sponsors

NDA 214121ACCORD HLTHCARE INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION5G/50ML0METHOTREXATEMETHOTREXATE

FDA Submissions

UNKNOWN; ORIG1AP2020-08-24STANDARD

Submissions Property Types

ORIG1Null40

CDER Filings

ACCORD HLTHCARE INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214121
            [companyName] => ACCORD HLTHCARE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHOTREXATE","activeIngredients":"METHOTREXATE","strength":"5G\/50ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/24\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/214121Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-24
        )

)

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