ACCORD HLTHCARE FDA Approval ANDA 213238

ANDA 213238

ACCORD HLTHCARE

FDA Drug Application

Application #213238

Application Sponsors

ANDA 213238ACCORD HLTHCARE

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION0.2MG/ML0GLYCOPYRROLATEGLYCOPYRROLATE

FDA Submissions

UNKNOWN; ORIG1AP2020-07-08STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

ACCORD HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213238
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLYCOPYRROLATE","activeIngredients":"GLYCOPYRROLATE","strength":"0.2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/08\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-08
        )

)

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