XIROMED FDA Approval ANDA 212227

ANDA 212227

XIROMED

FDA Drug Application

Application #212227

Application Sponsors

ANDA 212227XIROMED

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION0.2MG/ML0GLYCOPYRROLATEGLYCOPYRROLATE

FDA Submissions

UNKNOWN; ORIG1AP2021-03-04STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

XIROMED
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212227
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLYCOPYRROLATE","activeIngredients":"GLYCOPYRROLATE","strength":"0.2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/04\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-04
        )

)

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