ANDA 076494

HIKMA INTL PHARMS

FDA Drug Application

Application #076494

Application Sponsors

ANDA 076494

HIKMA INTL PHARMS

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	2004-01-14
LABELING; Labeling	SUPPL	4	AP	2006-08-08
LABELING; Labeling	SUPPL	10	AP	2010-04-16
LABELING; Labeling	SUPPL	12	AP	2015-04-16	STANDARD
LABELING; Labeling	SUPPL	15	AP	2019-11-26	STANDARD
LABELING; Labeling	SUPPL	16	AP	2019-11-26	STANDARD
LABELING; Labeling	SUPPL	17	AP	2019-11-26	STANDARD

Submissions Property Types

SUPPL	12	Null	15
SUPPL	15	Null	7
SUPPL	16	Null	7
SUPPL	17	Null	7

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76494
            [companyName] => HIKMA INTL PHARMS
            [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
        )

)