MACLEODS PHARMS LTD FDA Approval ANDA 206955

ANDA 206955

MACLEODS PHARMS LTD

FDA Drug Application

Application #206955

Application Sponsors

ANDA 206955MACLEODS PHARMS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, EXTENDED RELEASE;ORAL500MG0METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORAL750MG0METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2016-12-07STANDARD
LABELING; LabelingSUPPL3AP2019-11-05STANDARD
LABELING; LabelingSUPPL10AP2019-11-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2019-04-17STANDARD

Submissions Property Types

ORIG1Null15
SUPPL3Null7
SUPPL10Null15
SUPPL12Null7

TE Codes

001PrescriptionAB1
002PrescriptionAB

CDER Filings

MACLEODS PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206955
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"750MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/07\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/17\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/05\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/05\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-05
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.