CIPLA USA INC. FDA Approval ANDA 212424

ANDA 212424

CIPLA USA INC.

FDA Drug Application

Application #212424

Application Sponsors

ANDA 212424CIPLA USA INC.

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION1MG/0.5ML0PHYTONADIONEPHYTONADIONE
002INJECTABLE;INJECTION10MG/ML0PHYTONADIONEPHYTONADIONE

FDA Submissions

UNKNOWN; ORIG1AP2022-04-22STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB2
002PrescriptionAB2

CDER Filings

CIPLA USA INC.
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212424
            [companyName] => CIPLA USA INC.
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHYTONADIONE","activeIngredients":"PHYTONADIONE","strength":"1MG\/0.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PHYTONADIONE","activeIngredients":"PHYTONADIONE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/22\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-22
        )

)

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