ANDA 075337

PLIVA

FDA Drug Application

Application #075337

Documents

• Letter: 1999-05-26

Application Sponsors

ANDA 075337

PLIVA

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, DELAYED RELEASE;ORAL	375MG	0	NAPROXEN	NAPROXEN
002	TABLET, DELAYED RELEASE;ORAL	500MG	0	NAPROXEN	NAPROXEN

FDA Submissions

	ORIG	1	AP	1999-05-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-07-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-07-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-07-01
LABELING; Labeling	SUPPL	5	AP	2006-02-17
LABELING; Labeling	SUPPL	9	AP	2006-07-03

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75337
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"375MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"500MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NAPROXEN","submission":"NAPROXEN","actionType":"375MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NAPROXEN","submission":"NAPROXEN","actionType":"500MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)