SMITH AND NEPHEW FDA Approval ANDA 071681

ANDA 071681

SMITH AND NEPHEW

FDA Drug Application

Application #071681

Application Sponsors

ANDA 071681SMITH AND NEPHEW

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION0.4MG/ML0NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE

CDER Filings

SMITH AND NEPHEW
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71681
            [companyName] => SMITH AND NEPHEW
            [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.