NDA 017919

JANSSEN PHARMS

FDA Drug Application

Application #017919

Documents

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

Application Sponsors

NDA 017919

JANSSEN PHARMS

Marketing Status

• Discontinued: 002

Application Products

002

TABLET;ORAL-28

0.035MG;1MG

1

ORTHO-NOVUM 1/35-28

ETHINYL ESTRADIOL; NORETHINDRONE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1977-06-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1977-10-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1978-07-31	STANDARD
LABELING; Labeling	SUPPL	4	AP	1980-07-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1978-05-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1978-04-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1978-02-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1978-02-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1978-02-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1979-06-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1979-10-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1979-11-08	STANDARD
LABELING; Labeling	SUPPL	20	AP	1979-12-05
LABELING; Labeling	SUPPL	21	AP	1979-12-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1980-03-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1980-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1980-11-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1980-11-12	STANDARD
LABELING; Labeling	SUPPL	29	AP	1982-09-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1983-06-09	STANDARD
LABELING; Labeling	SUPPL	32	AP	1983-06-15
LABELING; Labeling	SUPPL	34	AP	1983-09-29
LABELING; Labeling	SUPPL	35	AP	1984-01-30
LABELING; Labeling	SUPPL	36	AP	1984-06-21
LABELING; Labeling	SUPPL	37	AP	1985-04-05
LABELING; Labeling	SUPPL	38	AP	1985-10-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1987-11-23	STANDARD
LABELING; Labeling	SUPPL	41	AP	1987-02-26
LABELING; Labeling	SUPPL	42	AP	1988-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1988-06-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1988-10-28	STANDARD
LABELING; Labeling	SUPPL	45	AP	1989-07-19
LABELING; Labeling	SUPPL	46	AP	1989-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1990-01-18	STANDARD
LABELING; Labeling	SUPPL	49	AP	1991-09-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1991-03-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	1994-03-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	1993-05-18	STANDARD
LABELING; Labeling	SUPPL	56	AP	1994-01-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	57	AP	1993-11-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	1995-02-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	59	AP	1995-09-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	1995-11-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	61	AP	1996-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	1996-04-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	63	AP	1997-01-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	64	AP	1997-02-24	STANDARD
LABELING; Labeling	SUPPL	65	AP	1999-08-27	STANDARD
LABELING; Labeling	SUPPL	66	AP	1999-01-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	67	AP	1998-04-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	68	AP	1998-04-28	STANDARD
LABELING; Labeling	SUPPL	69	AP	1999-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	70	AP	2000-01-05	STANDARD
LABELING; Labeling	SUPPL	71	AP	2000-06-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	73	AP	2001-07-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	74	AP	2002-02-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	75	AP	2002-06-03	STANDARD
LABELING; Labeling	SUPPL	86	AP	2013-10-03	STANDARD
LABELING; Labeling	SUPPL	89	AP	2012-06-18	STANDARD
LABELING; Labeling	SUPPL	90	AP	2013-10-02	STANDARD
LABELING; Labeling	SUPPL	92	AP	2013-10-02	STANDARD
LABELING; Labeling	SUPPL	96	AP	2013-10-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	98	AP	2014-09-11	STANDARD
LABELING; Labeling	SUPPL	99	AP	2015-10-29	STANDARD
LABELING; Labeling	SUPPL	100	AP	2017-08-09	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	31	Null	0
SUPPL	40	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	48	Null	0
SUPPL	50	Null	0
SUPPL	52	Null	0
SUPPL	55	Null	0
SUPPL	57	Null	0
SUPPL	58	Null	0
SUPPL	59	Null	0
SUPPL	60	Null	0
SUPPL	61	Null	0
SUPPL	62	Null	0
SUPPL	63	Null	0
SUPPL	64	Null	0
SUPPL	67	Null	0
SUPPL	68	Null	0
SUPPL	70	Null	0
SUPPL	73	Null	0
SUPPL	74	Null	0
SUPPL	75	Null	0
SUPPL	86	Null	15
SUPPL	89	Null	6
SUPPL	90	Null	7
SUPPL	92	Null	6
SUPPL	96	Null	7
SUPPL	98	Null	0
SUPPL	99	Null	6
SUPPL	100	Null	6

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17919
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ORTHO-NOVUM 1\/35-28","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE","strength":"0.035MG;1MG **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-100","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/017735s118,017919s100,018985s064lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2017","submission":"SUPPL-100","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/017735Orig1s118,017919Orig1s100,018985Orig1s064ltr.pdf\"}]","notes":""},{"actionDate":"10\/29\/2015","submission":"SUPPL-99","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-86","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-89","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/017735s107lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ORTHO-NOVUM 1\/35-28","submission":"ETHINYL ESTRADIOL; NORETHINDRONE","actionType":"0.035MG;1MG **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
        )

)