IGI LABS INC FDA Approval ANDA 072089

ANDA 072089

IGI LABS INC

FDA Drug Application

Application #072089

Application Sponsors

ANDA 072089IGI LABS INC

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION0.4MG/ML0NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE

CDER Filings

IGI LABS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72089
            [companyName] => IGI LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NALOXONE HYDROCHLORIDE","activeIngredients":"NALOXONE HYDROCHLORIDE","strength":"0.4MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NALOXONE HYDROCHLORIDE","submission":"NALOXONE HYDROCHLORIDE","actionType":"0.4MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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