TULEX PHARMS INC FDA Approval ANDA 212494

ANDA 212494

TULEX PHARMS INC

FDA Drug Application

Application #212494

Application Sponsors

ANDA 212494TULEX PHARMS INC

Marketing Status

Prescription001

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2020-08-11STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA

CDER Filings

TULEX PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212494
            [companyName] => TULEX PHARMS INC
            [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":"08\/11\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-11
        )

)

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