ANDA 079096

AMNEAL PHARMS NY

FDA Drug Application

Application #079096

Documents

• Other Important Information from FDA: 2009-01-06

Application Sponsors

ANDA 079096

AMNEAL PHARMS NY

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

220MG

0

NAPROXEN SODIUM

NAPROXEN SODIUM

FDA Submissions

	ORIG	1	AP	2008-12-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2015-02-24
LABELING; Labeling	SUPPL	4	AP	2011-01-31
LABELING; Labeling	SUPPL	8	AP	2015-02-24	STANDARD
LABELING; Labeling	SUPPL	9	AP	2014-08-11	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	7

CDER Filings

AMNEAL PHARMS NY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79096
            [companyName] => AMNEAL PHARMS NY
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN SODIUM","activeIngredients":"NAPROXEN SODIUM","strength":"220MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NAPROXEN SODIUM","submission":"NAPROXEN SODIUM","actionType":"220MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)