ANDA 205727

BELCHER

FDA Drug Application

Application #205727

Application Sponsors

ANDA 205727

BELCHER

Marketing Status

• Prescription: 001

Application Products

001

POWDER;ORAL, RECTAL

454GM/BOT

0

SODIUM POLYSTYRENE SULFONATE

SODIUM POLYSTYRENE SULFONATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-02-23

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

BELCHER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205727
            [companyName] => BELCHER
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM POLYSTYRENE SULFONATE","activeIngredients":"SODIUM POLYSTYRENE SULFONATE","strength":"454GM\/BOT","dosageForm":"POWDER;ORAL, RECTAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/23\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/16\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-03-16
        )

)