I3 PHARMS FDA Approval ANDA 213517

ANDA 213517

I3 PHARMS

FDA Drug Application

Application #213517

Application Sponsors

ANDA 213517I3 PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, EXTENDED RELEASE;ORAL500MG0RANOLAZINERANOLAZINE
002TABLET, EXTENDED RELEASE;ORAL1GM0RANOLAZINERANOLAZINE

FDA Submissions

UNKNOWN; ORIG1AP2022-04-27STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

I3 PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213517
            [companyName] => I3 PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"RANOLAZINE","activeIngredients":"RANOLAZINE","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RANOLAZINE","activeIngredients":"RANOLAZINE","strength":"1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/27\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-27
        )

)

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