ANDA 075481

AKORN INC

FDA Drug Application

Application #075481

Documents

• Letter: 2000-06-30

Application Sponsors

ANDA 075481

AKORN INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 5MG BASE/ML

0

MIDAZOLAM HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2000-06-30

Submissions Property Types

SUPPL

1

Null

15

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75481
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIDAZOLAM HYDROCHLORIDE","activeIngredients":"MIDAZOLAM HYDROCHLORIDE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MIDAZOLAM HYDROCHLORIDE","submission":"MIDAZOLAM HYDROCHLORIDE","actionType":"EQ 5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)