ANDA 091564

AM REGENT

FDA Drug Application

Application #091564

Application Sponsors

ANDA 091564

AM REGENT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

1%

0

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2015-08-14

Submissions Property Types

ORIG

1

Null

19

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91564
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE HYDROCHLORIDE","activeIngredients":"LIDOCAINE HYDROCHLORIDE","strength":"1%","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"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)