GRANULES PHARMS FDA Approval ANDA 213392

ANDA 213392

GRANULES PHARMS

FDA Drug Application

Application #213392

Application Sponsors

ANDA 213392GRANULES PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001SOLUTION;ORAL20MEQ/15ML0POTASSIUM CHLORIDEPOTASSIUM CHLORIDE
002SOLUTION;ORAL40MEQ/15ML0POTASSIUM CHLORIDEPOTASSIUM CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-01-29STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA
002PrescriptionAA

CDER Filings

GRANULES PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213392
            [companyName] => GRANULES PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"20MEQ\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"40MEQ\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"POTASSIUM CHLORIDE","submission":"POTASSIUM CHLORIDE","actionType":"20MEQ\/15ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"POTASSIUM CHLORIDE","submission":"POTASSIUM CHLORIDE","actionType":"40MEQ\/15ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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