NDA 019653

JANSSEN PHARMS

FDA Drug Application

Application #019653

Documents

• Letter: 2012-06-20
• Letter: 2013-10-04
• Letter: 2013-10-04
• Letter: 2013-10-04
• Letter: 2015-05-04
• Label: 2007-05-07
• Label: 2013-10-04
• Label: 2012-07-13
• Label: 2015-05-04
• Letter: 2007-05-09
• Letter: 2008-06-03
• Letter: 2013-10-04
• Review: 2009-01-12
• Review: 2009-01-12
• Review: 2009-01-12
• Review: 2009-01-12
• Review: 2009-01-12
• Review: 2009-01-12
• Review: 2009-01-12
• Review: 2009-01-12
• Review: 2009-01-12
• Review: 2009-01-12
• Review: 2009-01-12
• Review: 2009-01-12
• Review: 2009-01-12
• Review: 2009-01-12
• Label: 2017-08-10
• Letter: 2017-08-15

Application Sponsors

NDA 019653

JANSSEN PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL-21	0.035MG;0.25MG	0	ORTHO CYCLEN-21	ETHINYL ESTRADIOL; NORGESTIMATE
002	TABLET;ORAL-28	0.035MG;0.25MG	1	ORTHO CYCLEN-28	ETHINYL ESTRADIOL; NORGESTIMATE

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination	ORIG	1	AP	1989-12-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1991-05-23	STANDARD
LABELING; Labeling	SUPPL	3	AP	1991-09-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1992-06-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1992-10-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1995-02-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1993-11-04	STANDARD
LABELING; Labeling	SUPPL	11	AP	1994-06-28	STANDARD
LABELING; Labeling	SUPPL	12	AP	1996-01-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1995-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1995-11-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1996-02-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1996-08-02	STANDARD
LABELING; Labeling	SUPPL	17	AP	1998-04-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1996-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1999-10-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1999-11-02	STANDARD
LABELING; Labeling	SUPPL	22	AP	1999-11-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1999-09-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2000-01-05	STANDARD
LABELING; Labeling	SUPPL	25	AP	2000-06-05	STANDARD
LABELING; Labeling	SUPPL	27	AP	2001-01-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2001-07-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2002-01-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2002-06-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2002-09-06	STANDARD
S; Supplement	SUPPL	35	AP	2003-01-03	STANDARD
LABELING; Labeling	SUPPL	37	AP	2007-05-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	2008-05-30	N/A
LABELING; Labeling	SUPPL	46	AP	2013-10-03	STANDARD
LABELING; Labeling	SUPPL	48	AP	2012-06-18	STANDARD
LABELING; Labeling	SUPPL	49	AP	2013-10-02	STANDARD
LABELING; Labeling	SUPPL	51	AP	2013-10-02	STANDARD
LABELING; Labeling	SUPPL	54	AP	2013-10-02	STANDARD
LABELING; Labeling	SUPPL	56	AP	2015-05-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	57	AP	2016-06-22	STANDARD
LABELING; Labeling	SUPPL	58	AP	2017-08-09	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	35	Null	0
SUPPL	45	Null	4
SUPPL	46	Null	6
SUPPL	48	Null	15
SUPPL	49	Null	6
SUPPL	51	Null	15
SUPPL	54	Null	7
SUPPL	56	Null	7
SUPPL	57	Null	0
SUPPL	58	Null	15

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19653
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ORTHO CYCLEN-21","activeIngredients":"ETHINYL ESTRADIOL; NORGESTIMATE","strength":"0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL-21","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ORTHO CYCLEN-28","activeIngredients":"ETHINYL ESTRADIOL; NORGESTIMATE","strength":"0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL-28","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/09\/2017","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019653s058,019697s054lbl.pdf\"}]","notes":""},{"actionDate":"05\/01\/2015","submission":"SUPPL-56","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/019653s056,019697s052,021690s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2013","submission":"SUPPL-46","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019653Orig1s046,019697Orig1s042lbl.pdf\"}]","notes":""},{"actionDate":"06\/18\/2012","submission":"SUPPL-48","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019653s048lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2007","submission":"SUPPL-37","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019653s037,019697s034lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ORTHO CYCLEN-21","submission":"ETHINYL ESTRADIOL; NORGESTIMATE","actionType":"0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL-21","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ORTHO CYCLEN-28","submission":"ETHINYL ESTRADIOL; NORGESTIMATE","actionType":"0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-08-09
        )

)