ABHAI LLC FDA Approval ANDA 212453

ANDA 212453

ABHAI LLC

FDA Drug Application

Application #212453

Application Sponsors

ANDA 212453ABHAI LLC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL10MG0LEFLUNOMIDELEFLUNOMIDE
002TABLET;ORAL20MG0LEFLUNOMIDELEFLUNOMIDE

FDA Submissions

UNKNOWN; ORIG1AP2019-06-03STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ABHAI LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212453
            [companyName] => ABHAI LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEFLUNOMIDE","activeIngredients":"LEFLUNOMIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEFLUNOMIDE","activeIngredients":"LEFLUNOMIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/03\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-03
        )

)

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