ANDA 076629

MAYNE PHARMA

FDA Drug Application

Application #076629

Documents

• Letter: 2010-03-22

Application Sponsors

ANDA 076629

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.02MG,0.03MG,0.035MG;1MG,1MG,1MG

0

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

FDA Submissions

	ORIG	1	AP	2010-03-18
LABELING; Labeling	SUPPL	5	AP	2015-04-13
LABELING; Labeling	SUPPL	9	AP	2021-08-06	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-11-09	STANDARD
LABELING; Labeling	SUPPL	11	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	42
SUPPL	5	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	7
SUPPL	11	Null	15

TE Codes

001

Prescription

AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76629
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.02MG,0.03MG,0.035MG;1MG,1MG,1MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL","submission":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","actionType":"0.02MG,0.03MG,0.035MG;1MG,1MG,1MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)