NDA 019964

JANSSEN PHARMS

FDA Drug Application

Application #019964

Documents

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

Application Sponsors

NDA 019964

JANSSEN PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

CREAM;VAGINAL

0.8%

1

TERAZOL 3

TERCONAZOLE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1991-02-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1992-09-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1993-02-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1994-10-17	STANDARD
LABELING; Labeling	SUPPL	6	AP	1997-07-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1998-10-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1999-10-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1999-10-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-10-08	STANDARD
LABELING; Labeling	SUPPL	11	AP	2003-03-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-03-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2001-09-21	STANDARD
LABELING; Labeling	SUPPL	14	AP	2003-03-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-12-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2002-04-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2002-10-04	STANDARD
LABELING; Labeling	SUPPL	20	AP	2003-09-24	STANDARD
LABELING; Labeling	SUPPL	21	AP	2004-06-30	STANDARD
LABELING; Labeling	SUPPL	30	AP	2013-09-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2013-07-23	STANDARD
LABELING; Labeling	SUPPL	32	AP	2014-07-23	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	30	Null	6
SUPPL	31	Null	0
SUPPL	32	Null	6

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19964
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TERAZOL 3","activeIngredients":"TERCONAZOLE","strength":"0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"CREAM;VAGINAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]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-32","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-30","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-21","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-14","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-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/019641s016lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TERAZOL 3","submission":"TERCONAZOLE","actionType":"0.8% **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
        )

)