SAPTALIS PHARMS FDA Approval ANDA 211648

ANDA 211648

SAPTALIS PHARMS

FDA Drug Application

Application #211648

Application Sponsors

ANDA 211648SAPTALIS PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001SOLUTION;ORAL20MEQ/15ML0POTASSIUM CHLORIDEPOTASSIUM CHLORIDE
002SOLUTION;ORAL40MEQ/15ML0POTASSIUM CHLORIDEPOTASSIUM CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-05-21STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA
002PrescriptionAA

CDER Filings

SAPTALIS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211648
            [companyName] => SAPTALIS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"20MEQ\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"40MEQ\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-21
        )

)

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