MACLEODS PHARMS LTD FDA Approval ANDA 202696

ANDA 202696

MACLEODS PHARMS LTD

FDA Drug Application

Application #202696

Application Sponsors

ANDA 202696MACLEODS PHARMS LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL40MG0VALSARTANVALSARTAN
002TABLET;ORAL80MG0VALSARTANVALSARTAN
003TABLET;ORAL160MG0VALSARTANVALSARTAN
004TABLET;ORAL320MG0VALSARTANVALSARTAN

FDA Submissions

UNKNOWN; ORIG1AP2016-09-16
LABELING; LabelingSUPPL2AP2020-04-08STANDARD
LABELING; LabelingSUPPL13AP2019-09-04STANDARD
LABELING; LabelingSUPPL23AP2021-12-06STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null7
SUPPL13Null7
SUPPL23Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

MACLEODS PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202696
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"320MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/16\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/04\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/08\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-08
        )

)

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