ANDA 074163

WATSON LABS TEVA

FDA Drug Application

Application #074163

Application Sponsors

ANDA 074163

WATSON LABS TEVA

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	250MG	0	NAPROXEN	NAPROXEN
002	TABLET;ORAL	375MG	0	NAPROXEN	NAPROXEN
003	TABLET;ORAL	500MG	0	NAPROXEN	NAPROXEN

FDA Submissions

	ORIG	1	AP	1995-02-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1999-03-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-03-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-02-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-02-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-02-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2001-08-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-04-25

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0

CDER Filings

WATSON LABS TEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74163
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"375MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NAPROXEN","submission":"NAPROXEN","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NAPROXEN","submission":"NAPROXEN","actionType":"375MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NAPROXEN","submission":"NAPROXEN","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)