GRANULES FDA Approval ANDA 214686

ANDA 214686

GRANULES

FDA Drug Application

Application #214686

Application Sponsors

ANDA 214686GRANULES

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE, EXTENDED RELEASE;ORAL8MEQ0POTASSIUM CHLORIDEPOTASSIUM CHLORIDE
002CAPSULE, EXTENDED RELEASE;ORAL10MEQ0POTASSIUM CHLORIDEPOTASSIUM CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-02-16STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

GRANULES
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214686
            [companyName] => GRANULES
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"8MEQ","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"10MEQ","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/16\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-16
        )

)

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