ANNORA PHARMA FDA Approval ANDA 212903

ANDA 212903

ANNORA PHARMA

FDA Drug Application

Application #212903

Documents

Letter2021-07-08

Application Sponsors

ANDA 212903ANNORA PHARMA

Marketing Status

None (Tentative Approval)001

Application Products

001SOLUTION;ORAL17.5GM/BOT;3.13GM/BOT;1.6GM/BOT0SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATESODIUM SULFATE;POTASSIUM SULFATE;MAGNESIUM SULFATE

FDA Submissions

UNKNOWN; ORIG1TA2021-06-15STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

ANNORA PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212903
            [companyName] => ANNORA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE","activeIngredients":"SODIUM SULFATE;POTASSIUM SULFATE;MAGNESIUM SULFATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/15\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-15
        )

)

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