SUN PHARM FDA Approval ANDA 210473

ANDA 210473

SUN PHARM

FDA Drug Application

Application #210473

Documents

Letter2021-02-02

Application Sponsors

ANDA 210473SUN PHARM

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTIONEQ 0.5MG BASE/VIAL0EPOPROSTENOL SODIUMEPOPROSTENOL SODIUM
002INJECTABLE;INJECTIONEQ 1.5MG BASE/VIAL0EPOPROSTENOL SODIUMEPOPROSTENOL SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2021-01-15STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

SUN PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210473
            [companyName] => SUN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPOPROSTENOL SODIUM","activeIngredients":"EPOPROSTENOL SODIUM","strength":"EQ 0.5MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EPOPROSTENOL SODIUM","activeIngredients":"EPOPROSTENOL SODIUM","strength":"EQ 1.5MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/15\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-15
        )

)

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