Documents
Application Sponsors
Marketing Status
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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"CREAM;VAGINAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]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
)
)