YICHANG HUMANWELL FDA Approval ANDA 212561

ANDA 212561

YICHANG HUMANWELL

FDA Drug Application

Application #212561

Application Sponsors

ANDA 212561YICHANG HUMANWELL

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, EXTENDED RELEASE;ORAL10MEQ0POTASSIUM CHLORIDEPOTASSIUM CHLORIDE
002TABLET, EXTENDED RELEASE;ORAL20MEQ0POTASSIUM CHLORIDEPOTASSIUM CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2019-09-30STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB3
002PrescriptionAB3

CDER Filings

YICHANG HUMANWELL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212561
            [companyName] => YICHANG HUMANWELL
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"10MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"20MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/30\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-30
        )

)

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