LEADING PHARMA LLC FDA Approval ANDA 214140

ANDA 214140

LEADING PHARMA LLC

FDA Drug Application

Application #214140

Application Sponsors

ANDA 214140LEADING PHARMA LLC

Marketing Status

Prescription001

Application Products

001SYRUP;ORAL1.25GM/5ML0AMINOCAPROIC ACIDAMINOCAPROIC ACID

FDA Submissions

UNKNOWN; ORIG1AP2021-01-26STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA

CDER Filings

LEADING PHARMA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214140
            [companyName] => LEADING PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINOCAPROIC ACID","activeIngredients":"AMINOCAPROIC ACID","strength":"1.25GM\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-26
        )

)

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