Documents
Application Sponsors
Marketing Status
Application Products
| 001 | SOLUTION;ORAL | 10MG/ML | 1 | SPORANOX | ITRACONAZOLE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1997-02-21 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1998-07-27 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1998-07-27 | PRIORITY |
| LABELING; Labeling | SUPPL | 4 | AP | 2001-05-09 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2001-05-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2001-04-25 | PRIORITY |
| LABELING; Labeling | SUPPL | 7 | AP | 2002-09-11 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2002-07-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2002-10-10 | PRIORITY |
| LABELING; Labeling | SUPPL | 10 | AP | 2003-09-24 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2009-03-05 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2009-03-05 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2009-03-05 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2009-03-05 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2010-07-29 | UNKNOWN |
| LABELING; Labeling | SUPPL | 25 | AP | 2011-01-04 | UNKNOWN |
| LABELING; Labeling | SUPPL | 26 | AP | 2011-04-15 | UNKNOWN |
| LABELING; Labeling | SUPPL | 27 | AP | 2012-03-26 | UNKNOWN |
| LABELING; Labeling | SUPPL | 28 | AP | 2012-03-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2013-06-06 | PRIORITY |
| LABELING; Labeling | SUPPL | 32 | AP | 2014-06-09 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2015-04-16 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2017-03-17 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | 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 | 37 | AP | 2019-03-08 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2022-12-05 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 25 | Null | 6 |
| SUPPL | 26 | Null | 6 |
| SUPPL | 27 | Null | 6 |
| SUPPL | 28 | Null | 6 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 15 |
| SUPPL | 33 | Null | 6 |
| SUPPL | 35 | Null | 31 |
| SUPPL | 36 | Null | 6 |
| SUPPL | 37 | Null | 6 |
| SUPPL | 38 | Null | 6 |
TE Codes
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 20657
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"SPORANOX","activeIngredients":"ITRACONAZOLE","strength":"10MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"03\/08\/2019","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020657s037lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2017","submission":"SUPPL-36","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-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020657s035lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2015","submission":"SUPPL-33","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-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020657s032lbl.pdf\"}]","notes":""},{"actionDate":"03\/26\/2012","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020657s028lbl.pdf\"}]","notes":""},{"actionDate":"03\/26\/2012","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020657s027lbl.pdf\"}]","notes":""},{"actionDate":"04\/15\/2011","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020657s026lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2011","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020657s025lbl.pdf\"}]","notes":""},{"actionDate":"07\/29\/2010","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020657s024lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2009","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020657s011s018s019s021lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2009","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020657s011s018s019s021lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2009","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020657s011s018s019s021lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2009","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020657s011s018s019s021lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2003","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20657slr010_sporanox_lbl.pdf\"}]","notes":""},{"actionDate":"09\/11\/2002","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20657s7lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2002","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20657s8lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2001","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2001\\\/20-966S001_Sporanox_prntlbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2001","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2001\\\/20-966S001_Sporanox_prntlbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"SPORANOX","submission":"ITRACONAZOLE","actionType":"10MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-03-08
)
)