AKORN FDA Approval ANDA 085037

ANDA 085037

AKORN

FDA Drug Application

Application #085037

Application Sponsors

ANDA 085037AKORN

Marketing Status

Discontinued001
Discontinued002

Application Products

001INJECTABLE;INJECTION1%0LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE
002INJECTABLE;INJECTION2%0LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1976-07-29

CDER Filings

AKORN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85037
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE HYDROCHLORIDE","activeIngredients":"LIDOCAINE HYDROCHLORIDE","strength":"1%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LIDOCAINE HYDROCHLORIDE","activeIngredients":"LIDOCAINE HYDROCHLORIDE","strength":"2%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LIDOCAINE HYDROCHLORIDE","submission":"LIDOCAINE HYDROCHLORIDE","actionType":"1%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LIDOCAINE HYDROCHLORIDE","submission":"LIDOCAINE HYDROCHLORIDE","actionType":"2%","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.