ANDA 077234

HIKMA FARMACEUTICA

FDA Drug Application

Application #077234

Documents

• Other Important Information from FDA: 2008-02-28

Application Sponsors

ANDA 077234

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

AMIODARONE HYDROCHLORIDE

AMIODARONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2008-02-25
LABELING; Labeling	SUPPL	5	AP	2009-07-10

TE Codes

001

Prescription

AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77234
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMIODARONE HYDROCHLORIDE","activeIngredients":"AMIODARONE HYDROCHLORIDE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMIODARONE HYDROCHLORIDE","submission":"AMIODARONE HYDROCHLORIDE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)