ANDA 205743

PAR PHARM INC

FDA Drug Application

Application #205743

Application Sponsors

ANDA 205743

PAR PHARM INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

FOR SOLUTION;ORAL

12GM/PACKET;3.5GM/PACKET;10MG/PACKET

0

CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-11-21

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

PAR PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205743
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE","activeIngredients":"CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE","strength":"12GM\/PACKET;3.5GM\/PACKET;10MG\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/21\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-11-21
        )

)