ANDA 074789

CONTRACT PHARMACAL

FDA Drug Application

Application #074789

Application Sponsors

ANDA 074789

CONTRACT PHARMACAL

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

220MG

0

NAPROXEN SODIUM

NAPROXEN SODIUM

FDA Submissions

	ORIG	1	AP	1997-02-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-03-12
LABELING; Labeling	SUPPL	3	AP	1999-12-13
LABELING; Labeling	SUPPL	6	AP	2006-03-13

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0

CDER Filings

CONTRACT PHARMACAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74789
            [companyName] => CONTRACT PHARMACAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN SODIUM","activeIngredients":"NAPROXEN SODIUM","strength":"220MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NAPROXEN SODIUM","submission":"NAPROXEN SODIUM","actionType":"220MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)