NDA 018985

JANSSEN PHARMS

FDA Drug Application

Application #018985

Documents

• Letter: 2013-10-04
• Letter: 2013-10-04
• Letter: 2015-11-04
• Label: 2012-07-13
• Label: 2015-11-04
• Letter: 2012-06-20
• Letter: 2013-10-04
• Letter: 2013-10-04
• Label: 2013-10-04
• Label: 2017-08-10
• Letter: 2017-08-21

Application Sponsors

NDA 018985

JANSSEN PHARMS

Marketing Status

• Discontinued: 001
• Prescription: 002

Application Products

001	TABLET;ORAL-21	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	0	ORTHO-NOVUM 7/7/7-21	ETHINYL ESTRADIOL; NORETHINDRONE
002	TABLET;ORAL-28	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	1	ORTHO-NOVUM 7/7/7-28	ETHINYL ESTRADIOL; NORETHINDRONE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1984-04-04	STANDARD
LABELING; Labeling	SUPPL	2	AP	1985-04-05
LABELING; Labeling	SUPPL	3	AP	1985-10-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-11-23	STANDARD
LABELING; Labeling	SUPPL	6	AP	1987-02-02
LABELING; Labeling	SUPPL	7	AP	1988-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1988-06-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1988-10-28	STANDARD
LABELING; Labeling	SUPPL	10	AP	1989-07-19
LABELING; Labeling	SUPPL	11	AP	1989-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1990-01-18	STANDARD
LABELING; Labeling	SUPPL	14	AP	1991-09-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1991-03-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1994-03-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1993-05-18	STANDARD
LABELING; Labeling	SUPPL	20	AP	1994-01-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1993-11-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1995-02-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1995-09-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1995-11-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1996-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1996-04-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1997-01-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1997-02-24	STANDARD
LABELING; Labeling	SUPPL	29	AP	1999-08-27	STANDARD
LABELING; Labeling	SUPPL	30	AP	1999-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1998-04-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1998-04-28	STANDARD
LABELING; Labeling	SUPPL	33	AP	1999-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2000-01-05	STANDARD
LABELING; Labeling	SUPPL	35	AP	2000-06-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	2001-07-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2002-02-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2002-06-03	STANDARD
LABELING; Labeling	SUPPL	50	AP	2013-10-03	STANDARD
LABELING; Labeling	SUPPL	53	AP	2012-06-18	STANDARD
LABELING; Labeling	SUPPL	54	AP	2013-10-02	STANDARD
LABELING; Labeling	SUPPL	56	AP	2013-10-02	STANDARD
LABELING; Labeling	SUPPL	60	AP	2013-10-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	2014-09-11	STANDARD
LABELING; Labeling	SUPPL	63	AP	2015-10-29	STANDARD
LABELING; Labeling	SUPPL	64	AP	2017-08-09	STANDARD

Submissions Property Types

SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	34	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	50	Null	7
SUPPL	53	Null	6
SUPPL	54	Null	7
SUPPL	56	Null	7
SUPPL	60	Null	7
SUPPL	62	Null	0
SUPPL	63	Null	15
SUPPL	64	Null	6

TE Codes

002

Prescription

AB

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18985
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ORTHO-NOVUM 7\/7\/7-21","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE","strength":"0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG","dosageForm":"TABLET;ORAL-21","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ORTHO-NOVUM 7\/7\/7-28","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE","strength":"0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/09\/2017","submission":"SUPPL-64","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/017735s118,017919s100,018985s064lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2015","submission":"SUPPL-63","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/017735s117,017919s099,018985s063lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2013","submission":"SUPPL-50","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/017735Orig1s104,017919Orig1s086,018985Orig1s050lbl.pdf\"}]","notes":""},{"actionDate":"06\/18\/2012","submission":"SUPPL-53","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/017735s107lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ORTHO-NOVUM 7\/7\/7-21","submission":"ETHINYL ESTRADIOL; NORETHINDRONE","actionType":"0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG","submissionClassification":"TABLET;ORAL-21","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ORTHO-NOVUM 7\/7\/7-28","submission":"ETHINYL ESTRADIOL; NORETHINDRONE","actionType":"0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-08-09
        )

)