HETERO LABS LTD V FDA Approval ANDA 212789

ANDA 212789

HETERO LABS LTD V

FDA Drug Application

Application #212789

Application Sponsors

ANDA 212789HETERO LABS LTD V

Marketing Status

Prescription001

Application Products

001FOR SOLUTION;ORAL12GM/PACKET;3.5GM/PACKET;10MG/PACKET0SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACIDCITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

FDA Submissions

UNKNOWN; ORIG1AP2022-07-18STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

HETERO LABS LTD V
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212789
            [companyName] => HETERO LABS LTD V
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID","activeIngredients":"CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE","strength":"12GM\/PACKET;3.5GM\/PACKET;10MG\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/18\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-18
        )

)

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