LAURUS FDA Approval ANDA 213857

ANDA 213857

LAURUS

FDA Drug Application

Application #213857

Application Sponsors

ANDA 213857LAURUS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL100MG;25MG0LOPINAVIR AND RITONAVIRLOPINAVIR; RITONAVIR
002TABLET;ORAL200MG;50MG0LOPINAVIR AND RITONAVIRLOPINAVIR; RITONAVIR

FDA Submissions

UNKNOWN; ORIG1AP2022-03-21STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

LAURUS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213857
            [companyName] => LAURUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOPINAVIR AND RITONAVIR","activeIngredients":"LOPINAVIR; RITONAVIR","strength":"100MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LOPINAVIR AND RITONAVIR","activeIngredients":"LOPINAVIR; RITONAVIR","strength":"200MG;50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/21\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-21
        )

)

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