NDA 020071

ORGANON USA INC

FDA Drug Application

Application #020071

Documents

• Label: 2007-06-12
• Letter: 2004-08-11
• Letter: 2007-06-14
• Label: 2017-08-10
• Letter: 2017-08-15
• Letter: 2018-06-20
• Label: 2018-06-21

Application Sponsors

NDA 020071

ORGANON USA INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL-21	0.15MG;0.03MG	0	DESOGEN	DESOGESTREL; ETHINYL ESTRADIOL
002	TABLET;ORAL-28	0.15MG;0.03MG	0	DESOGEN	DESOGESTREL; ETHINYL ESTRADIOL

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination	ORIG	1	AP	1992-12-10	STANDARD
LABELING; Labeling	SUPPL	2	AP	1995-04-28	STANDARD
LABELING; Labeling	SUPPL	4	AP	1995-02-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1994-02-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1995-04-25	STANDARD
LABELING; Labeling	SUPPL	7	AP	1996-07-26	STANDARD
LABELING; Labeling	SUPPL	8	AP	1998-03-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1997-11-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1997-11-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1998-02-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1998-11-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-11-27	STANDARD
LABELING; Labeling	SUPPL	14	AP	2004-08-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2002-03-08	STANDARD
LABELING; Labeling	SUPPL	17	AP	2007-06-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2016-02-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2015-01-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2015-11-30	STANDARD
LABELING; Labeling	SUPPL	23	AP	2018-06-15	STANDARD
LABELING; Labeling	SUPPL	25	AP	2017-08-09	STANDARD

Submissions Property Types

SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	6
SUPPL	25	Null	15

CDER Filings

ORGANON USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20071
            [companyName] => ORGANON USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESOGEN","activeIngredients":"DESOGESTREL; ETHINYL ESTRADIOL","strength":"0.15MG;0.03MG","dosageForm":"TABLET;ORAL-21","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DESOGEN","activeIngredients":"DESOGESTREL; ETHINYL ESTRADIOL","strength":"0.15MG;0.03MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/15\/2018","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020071s023lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2017","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020071s025lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2007","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020071s017lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DESOGEN","submission":"DESOGESTREL; ETHINYL ESTRADIOL","actionType":"0.15MG;0.03MG","submissionClassification":"TABLET;ORAL-21","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DESOGEN","submission":"DESOGESTREL; ETHINYL ESTRADIOL","actionType":"0.15MG;0.03MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2018-06-15
        )

)