SPIL FDA Approval ANDA 212514

ANDA 212514

SPIL

FDA Drug Application

Application #212514

Documents

Letter2022-01-12

Application Sponsors

ANDA 212514SPIL

Marketing Status

Prescription001

Application Products

001INJECTABLE, LIPOSOMAL;INJECTION50MG/VIAL0AMPHOTERICIN BAMPHOTERICIN B

FDA Submissions

UNKNOWN; ORIG1AP2021-12-14STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

SPIL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212514
            [companyName] => SPIL
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMPHOTERICIN B","activeIngredients":"AMPHOTERICIN B","strength":"50MG\/VIAL","dosageForm":"INJECTABLE, LIPOSOMAL;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/14\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-14
        )

)

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