MACLEODS PHARMS LTD FDA Approval ANDA 204934

ANDA 204934

MACLEODS PHARMS LTD

FDA Drug Application

Application #204934

Application Sponsors

ANDA 204934MACLEODS PHARMS LTD

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2022-03-03

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

MACLEODS PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204934
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NIACIN","activeIngredients":"NIACIN","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NIACIN","activeIngredients":"NIACIN","strength":"1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/03\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-03
        )

)

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