NDA 019579

JANSSEN PHARMS

FDA Drug Application

Application #019579

Documents

• Letter: 2003-03-25
• Letter: 2013-10-01
• Label: 2003-03-20
• Label: 2004-07-01
• Label: 2014-07-24
• Letter: 2003-03-25
• Letter: 2003-09-30
• Letter: 2004-06-30
• Letter: 2014-07-25
• Label: 2003-03-20
• Label: 2013-09-27

Application Sponsors

NDA 019579

JANSSEN PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

CREAM;VAGINAL

0.4%

1

TERAZOL 7

TERCONAZOLE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1987-12-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1989-04-03	STANDARD
LABELING; Labeling	SUPPL	3	AP	1989-12-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1989-07-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1990-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1990-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1992-09-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1993-02-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1994-10-17	STANDARD
LABELING; Labeling	SUPPL	10	AP	1997-07-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1998-10-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1999-11-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1999-10-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1999-10-08	STANDARD
LABELING; Labeling	SUPPL	16	AP	2003-03-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2000-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2001-03-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2001-09-21	STANDARD
LABELING; Labeling	SUPPL	20	AP	2003-03-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2001-12-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2002-10-04	STANDARD
LABELING; Labeling	SUPPL	25	AP	2003-09-24	STANDARD
LABELING; Labeling	SUPPL	26	AP	2004-06-30	STANDARD
LABELING; Labeling	SUPPL	35	AP	2013-09-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2013-07-23	STANDARD
LABELING; Labeling	SUPPL	37	AP	2014-07-23	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	35	Null	6
SUPPL	36	Null	0
SUPPL	37	Null	15

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19579
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TERAZOL 7","activeIngredients":"TERCONAZOLE","strength":"0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"CREAM;VAGINAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/23\/2014","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019579s037,019641s030,019964s032lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2013","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019579s035,019641s028,019964s030lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2004","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/19579slr026,19641slr022,19964slr021_terazol_lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2003","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/019641s016lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2003","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/019641s016lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TERAZOL 7","submission":"TERCONAZOLE","actionType":"0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"CREAM;VAGINAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2014-07-23
        )

)