ANDA 040729

AMNEAL PHARMS NY

FDA Drug Application

Application #040729

Application Sponsors

ANDA 040729

AMNEAL PHARMS NY

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG;5MG

0

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

	ORIG	1	AP	2006-08-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2008-03-20

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0

CDER Filings

AMNEAL PHARMS NY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40729
            [companyName] => AMNEAL PHARMS NY
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"500MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"500MG;5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)