LUPIN LTD FDA Approval ANDA 211638

ANDA 211638

LUPIN LTD

FDA Drug Application

Application #211638

Application Sponsors

ANDA 211638LUPIN LTD

Marketing Status

Prescription001

Application Products

001FOR SUSPENSION;ORALEQ 10MG BASE/ML0SILDENAFIL CITRATESILDENAFIL CITRATE

FDA Submissions

UNKNOWN; ORIG1AP2022-03-23STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211638
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SILDENAFIL CITRATE","activeIngredients":"SILDENAFIL CITRATE","strength":"EQ 10MG BASE\/ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/23\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-23
        )

)

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