ANDA 072407

WATSON LABS TEVA

FDA Drug Application

Application #072407

Application Sponsors

ANDA 072407

WATSON LABS TEVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

EQ 600MG BASE

0

FENOPROFEN CALCIUM

FENOPROFEN CALCIUM

FDA Submissions

	ORIG	1	AP	1988-06-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1989-07-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1989-07-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1989-07-11
LABELING; Labeling	SUPPL	5	AP	1989-04-21
BIOEQUIV; Bioequivalence	SUPPL	6	AP	1989-05-24
LABELING; Labeling	SUPPL	8	AP	1991-05-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1997-01-31
LABELING; Labeling	SUPPL	10	AP	2016-05-09	STANDARD
LABELING; Labeling	SUPPL	11	AP	2016-05-11	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	15
SUPPL	11	Null	15

CDER Filings

WATSON LABS TEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72407
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOPROFEN CALCIUM","activeIngredients":"FENOPROFEN CALCIUM","strength":"EQ 600MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FENOPROFEN CALCIUM","submission":"FENOPROFEN CALCIUM","actionType":"EQ 600MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)