RISING FDA Approval ANDA 213820

ANDA 213820

RISING

FDA Drug Application

Application #213820

Documents

Letter2021-01-12

Application Sponsors

ANDA 213820RISING

Marketing Status

Prescription001

Application Products

001TABLET;ORAL500MG0NITAZOXANIDENITAZOXANIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-11-27STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

RISING
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213820
            [companyName] => RISING
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITAZOXANIDE","activeIngredients":"NITAZOXANIDE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/27\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-27
        )

)

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