LEADING PHARMA LLC FDA Approval ANDA 213928

ANDA 213928

LEADING PHARMA LLC

FDA Drug Application

Application #213928

Application Sponsors

ANDA 213928LEADING PHARMA LLC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL500MG0AMINOCAPROIC ACIDAMINOCAPROIC ACID
002TABLET;ORAL1GM0AMINOCAPROIC ACIDAMINOCAPROIC ACID

FDA Submissions

UNKNOWN; ORIG1AP2021-02-12STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

LEADING PHARMA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213928
            [companyName] => LEADING PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINOCAPROIC ACID","activeIngredients":"AMINOCAPROIC ACID","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMINOCAPROIC ACID","activeIngredients":"AMINOCAPROIC ACID","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/12\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-12
        )

)

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