ANDA 077182

MAYNE PHARMA

FDA Drug Application

Application #077182

Application Sponsors

ANDA 077182

MAYNE PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL-28	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	0	DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL
002	TABLET; ORAL-28	0.125MG/0.025MG	0	DESOGESTREL; ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL
003	TABLET; ORAL-28	0.15MG/0.025MG	0	DESOGESTREL; ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL

FDA Submissions

	ORIG	1	AP	2006-01-24
LABELING; Labeling	SUPPL	4	AP	2009-03-19
LABELING; Labeling	SUPPL	8	AP	2010-08-02
LABELING; Labeling	SUPPL	14	AP	2019-10-25	STANDARD

Submissions Property Types

SUPPL

14

Null

15

TE Codes

001

Prescription

AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77182
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESOGESTREL AND ETHINYL ESTRADIOL","activeIngredients":"DESOGESTREL; ETHINYL ESTRADIOL","strength":"0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DESOGESTREL; ETHINYL ESTRADIOL","activeIngredients":"DESOGESTREL; ETHINYL ESTRADIOL","strength":"0.125MG\/0.025MG","dosageForm":"TABLET; ORAL-28","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DESOGESTREL; ETHINYL ESTRADIOL","activeIngredients":"DESOGESTREL; ETHINYL ESTRADIOL","strength":"0.15MG\/0.025MG","dosageForm":"TABLET; ORAL-28","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DESOGESTREL AND ETHINYL ESTRADIOL","submission":"DESOGESTREL; ETHINYL ESTRADIOL","actionType":"0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DESOGESTREL; ETHINYL ESTRADIOL","submission":"DESOGESTREL; ETHINYL ESTRADIOL","actionType":"0.125MG\/0.025MG","submissionClassification":"TABLET; ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DESOGESTREL; ETHINYL ESTRADIOL","submission":"DESOGESTREL; ETHINYL ESTRADIOL","actionType":"0.15MG\/0.025MG","submissionClassification":"TABLET; ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)