STRIDES PHARMA FDA Approval ANDA 204559

ANDA 204559

STRIDES PHARMA

FDA Drug Application

Application #204559

Application Sponsors

ANDA 204559STRIDES PHARMA

Marketing Status

Prescription001

Application Products

001FOR SOLUTION;ORAL420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT0PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDEPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2015-04-13

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA

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
        )

)

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