ANDA 202333

EPIC PHARMA LLC

FDA Drug Application

Application #202333

Application Sponsors

ANDA 202333

EPIC PHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

POWDER;ORAL, RECTAL

453.6GM/BOT

0

SODIUM POLYSTYRENE SULFONATE

SODIUM POLYSTYRENE SULFONATE

FDA Submissions

ORIG

1

AP

2014-03-19

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AA

CDER Filings

EPIC PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202333
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM POLYSTYRENE SULFONATE","activeIngredients":"SODIUM POLYSTYRENE SULFONATE","strength":"453.6GM\/BOT","dosageForm":"POWDER;ORAL, RECTAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/19\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/25\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-25
        )

)