Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020966
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SPORANOX | ITRACONAZOLE | 10MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/30/1999 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20966lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20966ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020996_sporanox_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/23/2009 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020966s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020966s022ltr.pdf | |
03/05/2009 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020966s017s018s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020966s017,s018,s020ltr.pdf | |
03/05/2009 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020966s017s018s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020966s017,s018,s020ltr.pdf | |
03/05/2009 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020966s017s018s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020966s017,s018,s020ltr.pdf | |
07/14/2004 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20966s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20966s011ltr.pdf | |
10/10/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/16/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/02/2002 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/02/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/17/2002 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20966s6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20966slr006ltr.pdf | |
02/28/2002 | SUPPL-5 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20966s5ltr.pdf |
05/09/2001 | SUPPL-4 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox.cfm | |
05/09/2001 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox.cfm | |
10/25/1999 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/09/2001 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/23/2009 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020966s022lbl.pdf | |
03/05/2009 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020966s017s018s020lbl.pdf | |
03/05/2009 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020966s017s018s020lbl.pdf | |
03/05/2009 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020966s017s018s020lbl.pdf | |
07/14/2004 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20966s011lbl.pdf | |
07/17/2002 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20966s6lbl.pdf | |
05/09/2001 | SUPPL-4 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_prntlbl.pdf | |
05/09/2001 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_prntlbl.pdf | |
05/09/2001 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_prntlbl.pdf | |
03/30/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20966lbl.pdf |