PAR STERILE PRODUCTS FDA Approval ANDA 208405

ANDA 208405

PAR STERILE PRODUCTS

FDA Drug Application

Application #208405

Application Sponsors

ANDA 208405PAR STERILE PRODUCTS

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; ORIG1AP2017-04-26STANDARD
LABELING; LabelingSUPPL4AP2022-05-31STANDARD

Submissions Property Types

ORIG1Null15
SUPPL4Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

PAR STERILE PRODUCTS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208405
            [companyName] => PAR STERILE PRODUCTS
            [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\/26\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-04-26
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.