ASCENT PHARMS INC FDA Approval ANDA 216030

ANDA 216030

ASCENT PHARMS INC

FDA Drug Application

Application #216030

Application Sponsors

ANDA 216030ASCENT PHARMS INC

Marketing Status

Over-the-counter001
Over-the-counter002

Application Products

001TABLET;ORAL10MG0FAMOTIDINEFAMOTIDINE
002TABLET;ORAL20MG0FAMOTIDINEFAMOTIDINE

FDA Submissions

UNKNOWN; ORIG1AP2021-11-03STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

ASCENT PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216030
            [companyName] => ASCENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/03\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-03
        )

)

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