ANDA 087859

CMP PHARMA INC

FDA Drug Application

Application #087859

Application Sponsors

ANDA 087859

CMP PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL, RECTAL

15GM/60ML

0

SPS

SODIUM POLYSTYRENE SULFONATE

FDA Submissions

	ORIG	1	AP	1982-12-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1985-12-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1987-07-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1989-07-18
LABELING; Labeling	SUPPL	13	AP	1991-12-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1991-05-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2000-11-30
LABELING; Labeling	SUPPL	20	AP	2004-03-18
LABELING; Labeling	SUPPL	23	AP	2011-03-03
LABELING; Labeling	SUPPL	24	AP	2011-03-03
LABELING; Labeling	SUPPL	25	AP	2011-06-24

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	18	Null	0
SUPPL	25	Null	7

TE Codes

001

Prescription

AA

CDER Filings

CMP PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87859
            [companyName] => CMP PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SPS","activeIngredients":"SODIUM POLYSTYRENE SULFONATE","strength":"15GM\/60ML","dosageForm":"SUSPENSION;ORAL, RECTAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SPS","submission":"SODIUM POLYSTYRENE SULFONATE","actionType":"15GM\/60ML","submissionClassification":"SUSPENSION;ORAL, RECTAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)