ANDA 071044

WATSON LABS TEVA

FDA Drug Application

Application #071044

Application Sponsors

ANDA 071044

WATSON LABS TEVA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.035MG,0.035MG;0.5MG,1MG

0

NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)

ETHINYL ESTRADIOL; NORETHINDRONE

FDA Submissions

	ORIG	1	AP	1988-04-01
LABELING; Labeling	SUPPL	2	AP	1990-03-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1993-08-10
LABELING; Labeling	SUPPL	4	AP	1993-11-04
LABELING; Labeling	SUPPL	5	AP	1997-05-01
LABELING; Labeling	SUPPL	6	AP	2002-05-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-10-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-01-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-05-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2002-06-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2002-11-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2002-11-05
LABELING; Labeling	SUPPL	34	AP	2017-08-09	STANDARD
LABELING; Labeling	SUPPL	36	AP	2022-04-29	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	34	Null	7
SUPPL	36	Null	7

CDER Filings

WATSON LABS TEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71044
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORETHINDRONE AND ETHINYL ESTRADIOL (10\/11)","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE","strength":"0.035MG,0.035MG;0.5MG,1MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NORETHINDRONE AND ETHINYL ESTRADIOL (10\/11)","submission":"ETHINYL ESTRADIOL; NORETHINDRONE","actionType":"0.035MG,0.035MG;0.5MG,1MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)