Documents
Application Sponsors
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 10MG/ML | 0 | SPORANOX | ITRACONAZOLE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1999-03-30 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1999-10-25 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2001-05-09 | STANDARD |
EFFICACY; Efficacy | SUPPL | 4 | AP | 2001-05-09 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2002-02-28 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2002-07-17 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2002-08-02 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2002-08-02 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2002-09-16 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2002-10-10 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 2004-07-14 | STANDARD |
LABELING; Labeling | SUPPL | 17 | AP | 2009-03-05 | STANDARD |
LABELING; Labeling | SUPPL | 18 | AP | 2009-03-05 | STANDARD |
LABELING; Labeling | SUPPL | 20 | AP | 2009-03-05 | STANDARD |
LABELING; Labeling | SUPPL | 22 | AP | 2009-04-23 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | 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 | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 17 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 20 | Null | 0 |
SUPPL | 22 | Null | 0 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 20966
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"SPORANOX","activeIngredients":"ITRACONAZOLE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"04\/23\/2009","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020966s022lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2009","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020966s017s018s020lbl.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\\\/020966s017s018s020lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2009","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020966s017s018s020lbl.pdf\"}]","notes":""},{"actionDate":"07\/14\/2004","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20966s011lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2002","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20966s6lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2001","submission":"SUPPL-4","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-3","supplementCategories":"Labeling","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-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2001\\\/20-966S001_Sporanox_prntlbl.pdf\"}]","notes":""},{"actionDate":"03\/30\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/20966lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"SPORANOX","submission":"ITRACONAZOLE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2009-04-23
)
)