LUPIN PHARMS FDA Approval ANDA 211652

ANDA 211652

LUPIN PHARMS

FDA Drug Application

Application #211652

Documents

Letter2021-03-10

Application Sponsors

ANDA 211652LUPIN PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORAL100MG0DROXIDOPADROXIDOPA
002CAPSULE;ORAL200MG0DROXIDOPADROXIDOPA
003CAPSULE;ORAL300MG0DROXIDOPADROXIDOPA

FDA Submissions

UNKNOWN; ORIG1AP2021-02-18STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

LUPIN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211652
            [companyName] => LUPIN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DROXIDOPA","activeIngredients":"DROXIDOPA","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DROXIDOPA","activeIngredients":"DROXIDOPA","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DROXIDOPA","activeIngredients":"DROXIDOPA","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/18\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-18
        )

)

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