Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020657
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SPORANOX | ITRACONAZOLE | 10MG/ML | SOLUTION;ORAL | Prescription | AA | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/21/1997 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/18/2024 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020657s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020657Orig1s042ltr.pdf | |
| 02/05/2024 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020657s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020083Orig1s068; 020657Orig1s040ltr.pdf | |
| 10/19/2023 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020657s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020083Orig1s067, 020657Orig1s039ltr.pdf | |
| 12/05/2022 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020657s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020083Orig1s065,020657Orig1s038ltr.pdf | |
| 03/08/2019 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020657s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020657Orig1s037ltr.pdf | |
| 10/07/2017 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020083s061,020657s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020083Orig1s061,020657Orig1s036ltr.pdf |
| 03/17/2017 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020657s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020083Orig1s060,020657Orig1s035ltr.pdf | |
| 04/16/2015 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020083s058,020657s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020083Orig1s058,020657Orig1s033ltr.pdf | |
| 06/09/2014 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020657s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020083Orig1s053,020657Orig1s032ltr.pdf | |
| 06/06/2013 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/2012 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020657s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020657s027,s028ltr.pdf | |
| 03/26/2012 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020657s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020657s027,s028ltr.pdf | |
| 04/15/2011 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020657s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020657s026ltr.pdf | |
| 01/04/2011 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020657s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020657s025ltr.pdf | |
| 07/29/2010 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020657s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020083s046,020657s024ltr.pdf | |
| 03/05/2009 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020657s011s018s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020657s011,s018,s019,s021ltr.pdf | |
| 03/05/2009 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020657s011s018s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020657s011,s018,s019,s021ltr.pdf | |
| 03/05/2009 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020657s011s018s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020657s011,s018,s019,s021ltr.pdf | |
| 03/05/2009 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020657s011s018s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020657s011,s018,s019,s021ltr.pdf | |
| 09/24/2003 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20657slr010_sporanox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20657slr010ltr.pdf | |
| 10/10/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/17/2002 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20657s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20657slr008ltr.pdf | |
| 09/11/2002 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20657s7lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20657s7lbl.pdf | |
| 04/25/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/09/2001 | SUPPL-5 | 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-4 | 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 | |
| 07/27/1998 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/27/1998 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/20/1998 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/18/2024 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020657s042lbl.pdf | |
| 02/05/2024 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020657s040lbl.pdf | |
| 10/19/2023 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020657s039lbl.pdf | |
| 12/05/2022 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020657s038lbl.pdf | |
| 03/08/2019 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020657s037lbl.pdf | |
| 10/07/2017 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020083s061,020657s036lbl.pdf |
| 03/17/2017 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020657s035lbl.pdf | |
| 04/16/2015 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020083s058,020657s033lbl.pdf | |
| 06/09/2014 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020657s032lbl.pdf | |
| 03/26/2012 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020657s028lbl.pdf | |
| 03/26/2012 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020657s027lbl.pdf | |
| 04/15/2011 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020657s026lbl.pdf | |
| 01/04/2011 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020657s025lbl.pdf | |
| 07/29/2010 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020657s024lbl.pdf | |
| 03/05/2009 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020657s011s018s019s021lbl.pdf | |
| 03/05/2009 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020657s011s018s019s021lbl.pdf | |
| 03/05/2009 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020657s011s018s019s021lbl.pdf | |
| 03/05/2009 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020657s011s018s019s021lbl.pdf | |
| 09/24/2003 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20657slr010_sporanox_lbl.pdf | |
| 09/11/2002 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20657s7lbl.pdf | |
| 07/17/2002 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20657s8lbl.pdf | |
| 05/09/2001 | SUPPL-5 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_prntlbl.pdf | |
| 05/09/2001 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_prntlbl.pdf |
SPORANOX
SOLUTION;ORAL; 10MG/ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ITRACONAZOLE | ITRACONAZOLE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 205573 | AMNEAL PHARMS |
| ITRACONAZOLE | ITRACONAZOLE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 212239 | ANNORA PHARMA |
| SPORANOX | ITRACONAZOLE | 10MG/ML | SOLUTION;ORAL | Prescription | Yes | AA | 020657 | JANSSEN PHARMS |