ANDA 076916

MAYNE PHARMA

FDA Drug Application

Application #076916

Application Sponsors

ANDA 076916

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.15MG,N/A;0.02MG,0.01MG

0

DESOGESTREL AND ETHINYL ESTRADIOL

DESOGESTREL; ETHINYL ESTRADIOL

FDA Submissions

	ORIG	1	AP	2008-12-29
LABELING; Labeling	SUPPL	6	AP	2013-03-29	STANDARD
LABELING; Labeling	SUPPL	12	AP	2017-08-09	STANDARD
LABELING; Labeling	SUPPL	13	AP	2022-04-29	STANDARD

Submissions Property Types

SUPPL	6	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76916
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESOGESTREL AND ETHINYL ESTRADIOL","activeIngredients":"DESOGESTREL; ETHINYL ESTRADIOL","strength":"0.15MG,N\/A;0.02MG,0.01MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DESOGESTREL AND ETHINYL ESTRADIOL","submission":"DESOGESTREL; ETHINYL ESTRADIOL","actionType":"0.15MG,N\/A;0.02MG,0.01MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)