ANDA 071041

WATSON LABS TEVA

FDA Drug Application

Application #071041

Application Sponsors

ANDA 071041

WATSON LABS TEVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL-21

0.035MG,0.035MG;0.5MG,1MG

0

NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)

ETHINYL ESTRADIOL; NORETHINDRONE

FDA Submissions

	ORIG	1	AP	1991-09-24
LABELING; Labeling	SUPPL	2	AP	1997-05-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-05-21
LABELING; Labeling	SUPPL	4	AP	2017-08-09	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-04-29	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	15
SUPPL	5	Null	15

CDER Filings

WATSON LABS TEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71041
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORETHINDRONE AND ETHINYL ESTRADIOL (7\/14)","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE","strength":"0.035MG,0.035MG;0.5MG,1MG","dosageForm":"TABLET;ORAL-21","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NORETHINDRONE AND ETHINYL ESTRADIOL (7\/14)","submission":"ETHINYL ESTRADIOL; NORETHINDRONE","actionType":"0.035MG,0.035MG;0.5MG,1MG","submissionClassification":"TABLET;ORAL-21","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)