SAPTALIS PHARMS FDA Approval ANDA 212533

ANDA 212533

SAPTALIS PHARMS

FDA Drug Application

Application #212533

Application Sponsors

ANDA 212533SAPTALIS PHARMS

Marketing Status

Prescription001

Application Products

001SOLUTION;ORAL1GM/10ML0LEVOCARNITINELEVOCARNITINE

FDA Submissions

UNKNOWN; ORIG1AP2021-11-10STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA

CDER Filings

SAPTALIS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212533
            [companyName] => SAPTALIS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOCARNITINE","activeIngredients":"LEVOCARNITINE","strength":"1GM\/10ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/10\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-10
        )

)

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