ANDA 090313

ECI PHARMS LLC

FDA Drug Application

Application #090313

Application Sponsors

ANDA 090313

ECI PHARMS 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	2011-12-21
LABELING; Labeling	SUPPL	2	AP	2020-02-25	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001

Prescription

AA

CDER Filings

DISCOVERY THERAP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90313
            [companyName] => DISCOVERY THERAP
            [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":"SODIUM POLYSTYRENE SULFONATE","submission":"SODIUM POLYSTYRENE SULFONATE","actionType":"453.6GM\/BOT","submissionClassification":"POWDER;ORAL, RECTAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)