ANI PHARMS INC FDA Approval ANDA 211629

ANDA 211629

ANI PHARMS INC

FDA Drug Application

Application #211629

Application Sponsors

ANDA 211629ANI PHARMS INC

Marketing Status

Prescription001

Application Products

001UNKNOWNUNKNOWN0AMINOCAPROIC ACIDAMINOCAPROIC ACID

FDA Submissions

UNKNOWN; ORIG1AP2020-12-14STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

ANI PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211629
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINOCAPROIC ACID","activeIngredients":"AMINOCAPROIC ACID","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/14\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-14
        )

)

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