HANGZHOU ZHONGMEI FDA Approval ANDA 213821

ANDA 213821

HANGZHOU ZHONGMEI

FDA Drug Application

Application #213821

Application Sponsors

ANDA 213821HANGZHOU ZHONGMEI

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL25MG0ACARBOSEACARBOSE
002TABLET;ORAL50MG0ACARBOSEACARBOSE
003TABLET;ORAL100MG0ACARBOSEACARBOSE

FDA Submissions

UNKNOWN; ORIG1AP2020-08-18STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

HANGZHOU ZHONGMEI
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213821
            [companyName] => HANGZHOU ZHONGMEI
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACARBOSE","activeIngredients":"ACARBOSE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ACARBOSE","activeIngredients":"ACARBOSE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ACARBOSE","activeIngredients":"ACARBOSE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/18\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-18
        )

)

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