ELITE FDA Approval ANDA 212016

ANDA 212016

ELITE

FDA Drug Application

Application #212016

Application Sponsors

ANDA 212016ELITE

Marketing Status

Prescription001

Application Products

001TABLET, EXTENDED RELEASE;ORAL90MG0NIFEDIPINENIFEDIPINE

FDA Submissions

UNKNOWN; ORIG1AP2020-11-18STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB2

CDER Filings

ELITE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212016
            [companyName] => ELITE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NIFEDIPINE","activeIngredients":"NIFEDIPINE","strength":"90MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/18\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-18
        )

)

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