YICHANG HUMANWELL FDA Approval ANDA 212017

ANDA 212017

YICHANG HUMANWELL

FDA Drug Application

Application #212017

Application Sponsors

ANDA 212017YICHANG HUMANWELL

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001TABLET, EXTENDED RELEASE;ORAL500MG0NIACINNIACIN
002TABLET, EXTENDED RELEASE;ORAL750MG0NIACINNIACIN
003TABLET, EXTENDED RELEASE;ORAL1GM0NIACINNIACIN

FDA Submissions

UNKNOWN; ORIG1AP2019-06-10STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

YICHANG HUMANWELL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212017
            [companyName] => YICHANG HUMANWELL
            [docInserts] => ["",""]
            [products] => [{"drugName":"NIACIN","activeIngredients":"NIACIN","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NIACIN","activeIngredients":"NIACIN","strength":"750MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NIACIN","activeIngredients":"NIACIN","strength":"1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/10\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-10
        )

)

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