ANDA 204559

STRIDES PHARMA

FDA Drug Application

Application #204559

Application Sponsors

ANDA 204559

STRIDES PHARMA

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;ORAL

420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT

0

PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-04-13

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

STRIDES PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204559
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE","activeIngredients":"POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","strength":"420GM\/BOT;1.48GM\/BOT;5.72GM\/BOT;11.2GM\/BOT","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/13\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-04-13
        )

)