GRANULES FDA Approval ANDA 214452

ANDA 214452

GRANULES

FDA Drug Application

Application #214452

Application Sponsors

ANDA 214452GRANULES

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, EXTENDED RELEASE;ORAL10MEQ0POTASSIUM CHLORIDEPOTASSIUM CHLORIDE
002TABLET, EXTENDED RELEASE;ORAL20MEQ0POTASSIUM CHLORIDEPOTASSIUM CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-10-21STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB1
002PrescriptionAB1

CDER Filings

GRANULES
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214452
            [companyName] => GRANULES
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"10MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"20MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-21
        )

)

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