Documents
Application Sponsors
Marketing Status
Application Products
001 | CAPSULE;ORAL | 100MG | 1 | SPORANOX | ITRACONAZOLE |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1992-09-11 | PRIORITY |
LABELING; Labeling | SUPPL | 2 | AP | 1992-12-28 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1993-06-09 | |
EFFICACY; Efficacy | SUPPL | 4 | AP | 1994-03-29 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1994-05-09 | |
LABELING; Labeling | SUPPL | 6 | AP | 1993-11-09 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1994-10-12 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1995-09-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1995-09-15 | |
LABELING; Labeling | SUPPL | 12 | AP | 1996-05-23 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1996-03-22 | |
LABELING; Labeling | SUPPL | 17 | AP | 1996-12-10 | STANDARD |
LABELING; Labeling | SUPPL | 18 | AP | 1997-08-06 | STANDARD |
LABELING; Labeling | SUPPL | 19 | AP | 1997-08-06 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1997-11-03 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1998-07-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1998-07-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1999-02-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1999-09-29 | |
LABELING; Labeling | SUPPL | 25 | AP | 2001-05-09 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2001-03-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2002-02-27 | |
LABELING; Labeling | SUPPL | 28 | AP | 2002-07-17 | STANDARD |
LABELING; Labeling | SUPPL | 29 | AP | 2002-04-11 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2002-10-10 | |
LABELING; Labeling | SUPPL | 31 | AP | 2002-07-17 | STANDARD |
LABELING; Labeling | SUPPL | 33 | AP | 2003-11-10 | STANDARD |
LABELING; Labeling | SUPPL | 34 | AP | 2004-07-14 | STANDARD |
LABELING; Labeling | SUPPL | 35 | AP | 2004-07-14 | STANDARD |
LABELING; Labeling | SUPPL | 40 | AP | 2009-03-05 | STANDARD |
LABELING; Labeling | SUPPL | 41 | AP | 2009-03-05 | STANDARD |
LABELING; Labeling | SUPPL | 44 | AP | 2009-03-05 | STANDARD |
LABELING; Labeling | SUPPL | 46 | AP | 2010-07-29 | UNKNOWN |
LABELING; Labeling | SUPPL | 48 | AP | 2012-04-18 | UNKNOWN |
LABELING; Labeling | SUPPL | 49 | AP | 2012-04-18 | STANDARD |
LABELING; Labeling | SUPPL | 50 | AP | 2012-04-18 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 2013-03-01 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 2013-06-05 | |
LABELING; Labeling | SUPPL | 53 | AP | 2014-06-09 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 54 | AP | 2014-04-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 55 | AP | 2014-06-13 | |
LABELING; Labeling | SUPPL | 58 | AP | 2015-04-16 | STANDARD |
LABELING; Labeling | SUPPL | 60 | AP | 2017-03-17 | STANDARD |
LABELING; Labeling | SUPPL | 61 | AP | 2017-10-07 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
LABELING; Labeling | SUPPL | 62 | AP | 2018-05-08 | STANDARD |
LABELING; Labeling | SUPPL | 63 | AP | 2019-03-08 | STANDARD |
LABELING; Labeling | SUPPL | 65 | AP | 2022-12-05 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 11 |
SUPPL | 3 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 16 | Null | 0 |
SUPPL | 20 | Null | 0 |
SUPPL | 21 | Null | 0 |
SUPPL | 22 | Null | 0 |
SUPPL | 23 | Null | 0 |
SUPPL | 24 | Null | 0 |
SUPPL | 26 | Null | 0 |
SUPPL | 27 | Null | 0 |
SUPPL | 30 | Null | 0 |
SUPPL | 35 | Null | 9 |
SUPPL | 46 | Null | 7 |
SUPPL | 48 | Null | 7 |
SUPPL | 49 | Null | 7 |
SUPPL | 50 | Null | 15 |
SUPPL | 51 | Null | 0 |
SUPPL | 52 | Null | 0 |
SUPPL | 53 | Null | 6 |
SUPPL | 54 | Null | 0 |
SUPPL | 55 | Null | 0 |
SUPPL | 58 | Null | 7 |
SUPPL | 60 | Null | 7 |
SUPPL | 61 | Null | 7 |
SUPPL | 62 | Null | 7 |
SUPPL | 63 | Null | 15 |
SUPPL | 65 | Null | 6 |
TE Codes
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 20083
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"SPORANOX","activeIngredients":"ITRACONAZOLE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"03\/08\/2019","submission":"SUPPL-63","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020083s063lbl.pdf\"}]","notes":""},{"actionDate":"05\/08\/2018","submission":"SUPPL-62","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020083s062lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2017","submission":"SUPPL-61","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020083s061,020657s036lbl.pdf\"}]","notes":"Please see"},{"actionDate":"03\/17\/2017","submission":"SUPPL-60","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020083s060lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2015","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020083s058,020657s033lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2014","submission":"SUPPL-53","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020083s053lbl.pdf\"}]","notes":""},{"actionDate":"04\/18\/2012","submission":"SUPPL-50","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020083s048s049s050lbl.pdf\"}]","notes":""},{"actionDate":"04\/18\/2012","submission":"SUPPL-49","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020083s048s049s050lbl.pdf\"}]","notes":""},{"actionDate":"04\/18\/2012","submission":"SUPPL-48","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020083s048s049s050lbl.pdf\"}]","notes":""},{"actionDate":"07\/29\/2010","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020083s046lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2009","submission":"SUPPL-44","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020083s040s041s044lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2009","submission":"SUPPL-41","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020083s040s041s044lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2009","submission":"SUPPL-40","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020083s040s041s044lbl.pdf\"}]","notes":""},{"actionDate":"07\/14\/2004","submission":"SUPPL-35","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20083s034,035lbl.pdf\"}]","notes":""},{"actionDate":"07\/14\/2004","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20083s034,035lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2003","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20083slr033_sporanox_lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2002","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20083s28s31lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2002","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20083s28s31lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2002","submission":"SUPPL-29","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20083s29lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2001","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20083s25lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"SPORANOX","submission":"ITRACONAZOLE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-03-08
)
)