ANDA 211648

SAPTALIS PHARMS

FDA Drug Application

Application #211648

Application Sponsors

ANDA 211648

SAPTALIS PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;ORAL	20MEQ/15ML	0	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE
002	SOLUTION;ORAL	40MEQ/15ML	0	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-05-21

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AA
002	Prescription	AA

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
        )

)