ANDA 074538

MAYNE PHARMA

FDA Drug Application

Application #074538

Documents

• Label: 2014-01-24
• Review: 2005-07-22

Application Sponsors

ANDA 074538

MAYNE PHARMA

Marketing Status

• Discontinued: 001
• Prescription: 002

Application Products

001	TABLET;ORAL-21	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	0	TRIVORA-21	ETHINYL ESTRADIOL; LEVONORGESTREL
002	TABLET;ORAL-28	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	0	TRIVORA-28	ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

	ORIG	1	AP	1997-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-02-10
LABELING; Labeling	SUPPL	17	AP	2007-04-03
LABELING; Labeling	SUPPL	25	AP	2017-08-09	STANDARD
LABELING; Labeling	SUPPL	27	AP	2022-02-22	STANDARD
LABELING; Labeling	SUPPL	28	AP	2022-04-29	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	25	Null	7
SUPPL	27	Null	15
SUPPL	28	Null	7

TE Codes

002

Prescription

AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74538
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIVORA-21","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG","dosageForm":"TABLET;ORAL-21","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRIVORA-28","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/03\/2007","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/074538s017lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TRIVORA-21","submission":"ETHINYL ESTRADIOL; LEVONORGESTREL","actionType":"0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG","submissionClassification":"TABLET;ORAL-21","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRIVORA-28","submission":"ETHINYL ESTRADIOL; LEVONORGESTREL","actionType":"0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2007-04-03
        )

)