ANDA 070686

MAYNE PHARMA

FDA Drug Application

Application #070686

Application Sponsors

ANDA 070686

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.035MG;0.5MG

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	2002-05-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-08-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2001-10-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2002-05-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2002-06-26
LABELING; Labeling	SUPPL	37	AP	2022-04-22	STANDARD
LABELING; Labeling	SUPPL	38	AP	2022-04-29	STANDARD

Submissions Property Types

SUPPL	7	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	37	Null	15
SUPPL	38	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70686
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORETHINDRONE AND ETHINYL ESTRADIOL","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE","strength":"0.035MG;0.5MG","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;0.5MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)