ANDA 076088

BEN VENUE

FDA Drug Application

Application #076088

Documents

• Other Important Information from FDA: 2005-07-28

Application Sponsors

ANDA 076088

BEN VENUE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

AMIODARONE HYDROCHLORIDE

AMIODARONE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2002-10-15

Submissions Property Types

ORIG

1

Null

0

CDER Filings

BEN VENUE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76088
            [companyName] => BEN VENUE
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMIODARONE HYDROCHLORIDE","activeIngredients":"AMIODARONE HYDROCHLORIDE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMIODARONE HYDROCHLORIDE","submission":"AMIODARONE HYDROCHLORIDE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)