Application Sponsors
| ANDA 089910 | CMP PHARMA INC | |
Marketing Status
Application Products
| 001 | POWDER;ORAL, RECTAL | 454GM/BOT | 0 | SODIUM POLYSTYRENE SULFONATE | SODIUM POLYSTYRENE SULFONATE |
FDA Submissions
| ORIG | 1 | AP | 1989-01-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1991-12-04 | |
| LABELING; Labeling | SUPPL | 4 | AP | 1992-11-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2000-10-31 | |
| LABELING; Labeling | SUPPL | 8 | AP | 2012-09-25 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2018-01-29 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 15 |
TE Codes
CDER Filings
CMP PHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 89910
[companyName] => CMP PHARMA INC
[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":"SODIUM POLYSTYRENE SULFONATE","submission":"SODIUM POLYSTYRENE SULFONATE","actionType":"454GM\/BOT","submissionClassification":"POWDER;ORAL, RECTAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)