I3 PHARMS FDA Approval ANDA 212053

ANDA 212053

I3 PHARMS

FDA Drug Application

Application #212053

Application Sponsors

ANDA 212053I3 PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL375MG0CHLORZOXAZONECHLORZOXAZONE
002TABLET;ORAL750MG0CHLORZOXAZONECHLORZOXAZONE

FDA Submissions

UNKNOWN; ORIG1AP2020-09-15STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

I3 PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212053
            [companyName] => I3 PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORZOXAZONE","activeIngredients":"CHLORZOXAZONE","strength":"375MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CHLORZOXAZONE","activeIngredients":"CHLORZOXAZONE","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/14\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-14
        )

)

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