VKT PHARMA FDA Approval ANDA 215630

ANDA 215630

VKT PHARMA

FDA Drug Application

Application #215630

Application Sponsors

ANDA 215630VKT PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL20MG0FAMOTIDINEFAMOTIDINE
002TABLET;ORAL40MG0FAMOTIDINEFAMOTIDINE

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

VKT PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215630
            [companyName] => VKT PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FAMOTIDINE","submission":"FAMOTIDINE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FAMOTIDINE","submission":"FAMOTIDINE","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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