HONG KONG FDA Approval ANDA 212804

ANDA 212804

HONG KONG

FDA Drug Application

Application #212804

Application Sponsors

ANDA 212804HONG KONG

Marketing Status

Prescription001
Prescription002

Application Products

001SOLUTION;INTRAVENOUS5MG/10ML (0.5MG/ML)0NEOSTIGMINE METHYLSULFATENEOSTIGMINE METHYLSULFATE
002SOLUTION;INTRAVENOUS10MG/10ML (1MG/ML)0NEOSTIGMINE METHYLSULFATENEOSTIGMINE METHYLSULFATE

FDA Submissions

UNKNOWN; ORIG1AP2021-04-05STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

HONG KONG
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212804
            [companyName] => HONG KONG
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEOSTIGMINE METHYLSULFATE","activeIngredients":"NEOSTIGMINE METHYLSULFATE","strength":"5MG\/10ML (0.5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NEOSTIGMINE METHYLSULFATE","activeIngredients":"NEOSTIGMINE METHYLSULFATE","strength":"10MG\/10ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/05\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-05
        )

)

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