NIVAGEN PHARMS INC FDA Approval ANDA 212591

ANDA 212591

NIVAGEN PHARMS INC

FDA Drug Application

Application #212591

Application Sponsors

ANDA 212591NIVAGEN PHARMS INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION0.2MG/ML0GLYCOPYRROLATEGLYCOPYRROLATE

FDA Submissions

UNKNOWN; ORIG1AP2021-10-13STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

NIVAGEN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212591
            [companyName] => NIVAGEN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLYCOPYRROLATE","activeIngredients":"GLYCOPYRROLATE","strength":"0.2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/13\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-13
        )

)

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