ANDA 076394

PAR STERILE PRODUCTS

FDA Drug Application

Application #076394

Documents

• Other Important Information from FDA: 2005-07-28
• Letter: 2003-12-24
• Label: 2003-12-24
• Review: 2003-12-24

Application Sponsors

ANDA 076394

PAR STERILE PRODUCTS

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

AMIODARONE HYDROCHLORIDE

AMIODARONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2003-04-25
LABELING; Labeling	SUPPL	6	AP	2005-06-09
LABELING; Labeling	SUPPL	7	AP	2005-08-26
LABELING; Labeling	SUPPL	8	AP	2006-05-12

CDER Filings

PAR STERILE PRODUCTS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76394
            [companyName] => PAR STERILE PRODUCTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMIODARONE HYDROCHLORIDE","activeIngredients":"AMIODARONE HYDROCHLORIDE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/25\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"AMIODARONE HYDROCHLORIDE","submission":"AMIODARONE HYDROCHLORIDE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2003-04-25
        )

)