AGENIX FDA Approval ANDA 215510

ANDA 215510

AGENIX

FDA Drug Application

Application #215510

Application Sponsors

ANDA 215510AGENIX

Marketing Status

Prescription001

Application Products

001SOLUTION;ORAL0.25GM/ML0AMINOCAPROIC ACIDAMINOCAPROIC ACID

FDA Submissions

UNKNOWN; ORIG1AP2022-03-23STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA

CDER Filings

AGENIX
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215510
            [companyName] => AGENIX
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINOCAPROIC ACID","activeIngredients":"AMINOCAPROIC ACID","strength":"0.25GM\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/23\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-23
        )

)

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