NDA 020301

JANSSEN PHARMS

FDA Drug Application

Application #020301

Documents

• Letter: 2012-06-20
• Letter: 2013-10-04
• Letter: 2013-10-04
• Letter: 2015-12-02
• Label: 2013-10-04
• Label: 2012-07-13
• Label: 2015-12-02
• Letter: 2013-10-04
• Letter: 2013-10-04
• Label: 2017-08-09
• Letter: 2017-08-15

Application Sponsors

NDA 020301

JANSSEN PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

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

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1992-12-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-01-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1993-11-04	STANDARD
LABELING; Labeling	SUPPL	4	AP	1995-06-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1996-02-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-03-04	STANDARD
LABELING; Labeling	SUPPL	8	AP	1996-02-14	STANDARD
LABELING; Labeling	SUPPL	9	AP	1997-02-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1998-11-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1998-11-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1999-03-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2000-01-05	STANDARD
LABELING; Labeling	SUPPL	15	AP	2001-06-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2001-06-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2002-02-21	STANDARD
LABELING; Labeling	SUPPL	25	AP	2013-10-03	STANDARD
LABELING; Labeling	SUPPL	27	AP	2012-06-18	STANDARD
LABELING; Labeling	SUPPL	28	AP	2013-10-02	STANDARD
LABELING; Labeling	SUPPL	30	AP	2013-10-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2014-04-08	STANDARD
LABELING; Labeling	SUPPL	34	AP	2013-10-02	STANDARD
LABELING; Labeling	SUPPL	36	AP	2015-12-01	STANDARD
LABELING; Labeling	SUPPL	37	AP	2017-08-09	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	25	Null	6
SUPPL	27	Null	15
SUPPL	28	Null	15
SUPPL	30	Null	15
SUPPL	33	Null	0
SUPPL	34	Null	15
SUPPL	36	Null	15
SUPPL	37	Null	6

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20301
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ORTHO-CEPT","activeIngredients":"DESOGESTREL; ETHINYL ESTRADIOL","strength":"0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL-21","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ORTHO-CEPT","activeIngredients":"DESOGESTREL; ETHINYL ESTRADIOL","strength":"0.15MG;0.03MG **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-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020301s037lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2015","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020301s036lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2013","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020301Orig1s025lbl.pdf\"}]","notes":""},{"actionDate":"06\/18\/2012","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020301s027lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ORTHO-CEPT","submission":"DESOGESTREL; ETHINYL ESTRADIOL","actionType":"0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL-21","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ORTHO-CEPT","submission":"DESOGESTREL; ETHINYL ESTRADIOL","actionType":"0.15MG;0.03MG **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
        )

)