ANDA 070687

WATSON LABS TEVA

FDA Drug Application

Application #070687

Application Sponsors

ANDA 070687

WATSON LABS TEVA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.035MG;1MG

0

NORETHINDRONE AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; NORETHINDRONE

FDA Submissions

	ORIG	1	AP	1987-01-29
LABELING; Labeling	SUPPL	3	AP	1987-09-28
LABELING; Labeling	SUPPL	4	AP	1987-11-19
LABELING; Labeling	SUPPL	5	AP	1989-07-28
LABELING; Labeling	SUPPL	6	AP	1990-03-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1993-08-10
LABELING; Labeling	SUPPL	8	AP	1993-11-04
LABELING; Labeling	SUPPL	9	AP	1997-05-01
LABELING; Labeling	SUPPL	10	AP	1997-11-17
LABELING; Labeling	SUPPL	11	AP	2002-05-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2001-08-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2001-10-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2002-05-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2002-06-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2002-12-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2002-12-13
LABELING; Labeling	SUPPL	43	AP	2022-02-24	STANDARD
LABELING; Labeling	SUPPL	44	AP	2022-04-29	STANDARD

Submissions Property Types

SUPPL	7	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	43	Null	15
SUPPL	44	Null	15

TE Codes

001

Prescription

AB

CDER Filings

WATSON LABS TEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70687
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORETHINDRONE AND ETHINYL ESTRADIOL","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE","strength":"0.035MG;1MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NORETHINDRONE AND ETHINYL ESTRADIOL","submission":"ETHINYL ESTRADIOL; NORETHINDRONE","actionType":"0.035MG;1MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)