STRIDES PHARMA FDA Approval ANDA 215469

ANDA 215469

STRIDES PHARMA

FDA Drug Application

Application #215469

Application Sponsors

ANDA 215469STRIDES PHARMA

Marketing Status

None (Tentative Approval)001

FDA Submissions

UNKNOWN; ORIG1TA2022-01-06STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215469
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM SULFATE;POTASSIUM SULFATE;MAGNESIUM SULFATE","activeIngredients":"SODIUM SULFATE;POTASSIUM SULFATE;MAGNESIUM SULFATE","strength":"17.5G;3013G;1.6G","dosageForm":"SOLUTION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/06\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-06
        )

)

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