ANDA 074635

CONTRACT PHARMACAL

FDA Drug Application

Application #074635

Application Sponsors

ANDA 074635

CONTRACT PHARMACAL

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

220MG

0

NAPROXEN SODIUM

NAPROXEN SODIUM

FDA Submissions

	ORIG	1	AP	1997-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-04-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1999-02-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-02-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-03-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-03-03
LABELING; Labeling	SUPPL	8	AP	1999-08-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2000-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2000-09-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2002-04-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2002-04-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2002-09-04
LABELING; Labeling	SUPPL	17	AP	2006-03-13

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0

CDER Filings

CONTRACT PHARMACAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74635
            [companyName] => CONTRACT PHARMACAL
            [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
        )

)