ANDA 204558

STRIDES PHARMA

FDA Drug Application

Application #204558

Application Sponsors

ANDA 204558

STRIDES PHARMA

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;ORAL

236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT

0

POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES

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

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-12-21

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

STRIDES PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204558
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES","activeIngredients":"POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS","strength":"236GM\/BOT;2.97GM\/BOT;6.74GM\/BOT;5.86GM\/BOT;22.74GM\/BOT","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/21\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-21
        )

)