Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020083
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SPORANOX | ITRACONAZOLE | 100MG | CAPSULE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 09/11/1992 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 10/25/2024 | SUPPL-71 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020083s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020083Orig1s071ltr.pdf | |
| 02/05/2024 | SUPPL-68 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020083s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020083Orig1s068; 020657Orig1s040ltr.pdf | |
| 10/19/2023 | SUPPL-67 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020083s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020083Orig1s067, 020657Orig1s039ltr.pdf | |
| 12/05/2022 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020083s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020083Orig1s065,020657Orig1s038ltr.pdf | |
| 03/08/2019 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020083s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020083Orig1s063ltr.pdf | |
| 05/08/2018 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020083s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/20083Orig1s062ltr.pdf | |
| 10/07/2017 | SUPPL-61 | 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-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020083s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020083Orig1s060,020657Orig1s035ltr.pdf | |
| 04/16/2015 | SUPPL-58 | 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 | |
| 06/13/2014 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/11/2014 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/2014 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020083s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020083Orig1s053,020657Orig1s032ltr.pdf | |
| 06/05/2013 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/2013 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/2012 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020083s048s049s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020083s048,s049,s050ltr.pdf | |
| 04/18/2012 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020083s048s049s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020083s048,s049,s050ltr.pdf | |
| 04/18/2012 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020083s048s049s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020083s048,s049,s050ltr.pdf | |
| 07/29/2010 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020083s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020083s046,020657s024ltr.pdf | |
| 03/05/2009 | SUPPL-44 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020083s040s041s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020083s040,s041,s044ltr.pdf | |
| 03/05/2009 | SUPPL-41 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020083s040s041s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020083s040,s041,s044ltr.pdf | |
| 03/05/2009 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020083s040s041s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020083s040,s041,s044ltr.pdf | |
| 07/14/2004 | SUPPL-35 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20083s034,035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20083s034,035ltr.pdf | |
| 07/14/2004 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20083s034,035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20083s034,035ltr.pdf | |
| 11/10/2003 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20083slr033_sporanox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20083slr033ltr.pdf | |
| 07/17/2002 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20083s28s31lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20083slr028,031ltr.pdf | |
| 10/10/2002 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/11/2002 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20083s29lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20083s29ltr.pdf | |
| 07/17/2002 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20083s28s31lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20083slr028,031ltr.pdf | |
| 02/27/2002 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/21/2001 | SUPPL-26 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 05/09/2001 | SUPPL-25 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20083s25lbl.pdf | |
| 09/29/1999 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/17/1999 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/27/1998 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/27/1998 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/03/1997 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/06/1997 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 08/06/1997 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 12/10/1996 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 03/22/1996 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/23/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 09/15/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/12/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/09/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1994 | SUPPL-4 | Efficacy-New Indication |
Label is not available on this site. |
||
| 06/09/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/13/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/25/2024 | SUPPL-71 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020083s071lbl.pdf | |
| 10/25/2024 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020083s071lbl.pdf | |
| 02/05/2024 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020083s068lbl.pdf | |
| 10/19/2023 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020083s067lbl.pdf | |
| 10/19/2023 | SUPPL-67 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020083s067lbl.pdf | |
| 12/05/2022 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020083s065lbl.pdf | |
| 03/08/2019 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020083s063lbl.pdf | |
| 05/08/2018 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020083s062lbl.pdf | |
| 10/07/2017 | SUPPL-61 | 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-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020083s060lbl.pdf | |
| 04/16/2015 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020083s058,020657s033lbl.pdf | |
| 06/09/2014 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020083s053lbl.pdf | |
| 04/18/2012 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020083s048s049s050lbl.pdf | |
| 04/18/2012 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020083s048s049s050lbl.pdf | |
| 04/18/2012 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020083s048s049s050lbl.pdf | |
| 07/29/2010 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020083s046lbl.pdf | |
| 03/05/2009 | SUPPL-44 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020083s040s041s044lbl.pdf | |
| 03/05/2009 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020083s040s041s044lbl.pdf | |
| 03/05/2009 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020083s040s041s044lbl.pdf | |
| 07/14/2004 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20083s034,035lbl.pdf | |
| 07/14/2004 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20083s034,035lbl.pdf | |
| 11/10/2003 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20083slr033_sporanox_lbl.pdf | |
| 07/17/2002 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20083s28s31lbl.pdf | |
| 07/17/2002 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20083s28s31lbl.pdf | |
| 04/11/2002 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20083s29lbl.pdf | |
| 05/09/2001 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20083s25lbl.pdf |
SPORANOX
CAPSULE;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ITRACONAZOLE | ITRACONAZOLE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 206741 | ALEMBIC |
| ITRACONAZOLE | ITRACONAZOLE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 208591 | ALKEM LABS LTD |
| ITRACONAZOLE | ITRACONAZOLE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 205080 | AMNEAL PHARMS |
| ITRACONAZOLE | ITRACONAZOLE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 076104 | SANDOZ |
| ITRACONAZOLE | ITRACONAZOLE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 209460 | TORRENT |
| ITRACONAZOLE | ITRACONAZOLE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 204672 | ZYDUS PHARMS |
| SPORANOX | ITRACONAZOLE | 100MG | CAPSULE;ORAL | Prescription | Yes | AB | 020083 | JANSSEN PHARMS |