ANDA 075431

AKORN INC

FDA Drug Application

Application #075431

Documents

• Letter: 1999-12-29

Application Sponsors

ANDA 075431

AKORN INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

5MG/ML

0

LABETALOL HYDROCHLORIDE

LABETALOL HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

1999-11-29

TE Codes

001

Prescription

AP

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75431
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LABETALOL HYDROCHLORIDE","activeIngredients":"LABETALOL HYDROCHLORIDE","strength":"5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LABETALOL HYDROCHLORIDE","submission":"LABETALOL HYDROCHLORIDE","actionType":"5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)