LUPIN LTD FDA Approval ANDA 205588

ANDA 205588

LUPIN LTD

FDA Drug Application

Application #205588

Application Sponsors

ANDA 205588LUPIN LTD

Marketing Status

Prescription001

Application Products

001TABLET;ORAL-280.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG0NORGESTIMATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORGESTIMATE

FDA Submissions

UNKNOWN; ORIG1AP2016-04-26STANDARD
LABELING; LabelingSUPPL3AP2019-04-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2019-07-03
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2021-10-18STANDARD
LABELING; LabelingSUPPL9AP2022-04-29STANDARD

Submissions Property Types

ORIG1Null15
SUPPL3Null7
SUPPL6Null15
SUPPL8Null7
SUPPL9Null15

TE Codes

001PrescriptionAB

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205588
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORGESTIMATE AND ETHINYL ESTRADIOL","activeIngredients":"ETHINYL ESTRADIOL; NORGESTIMATE","strength":"0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/26\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/03\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/26\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-07-03
        )

)

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