Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020083
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
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
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 205991 ACCORD HLTHCARE
ITRACONAZOLE ITRACONAZOLE 100MG CAPSULE;ORAL Prescription No AB 206741 ALEMBIC PHARMS LTD
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 203445 JUBILANT GENERICS
ITRACONAZOLE ITRACONAZOLE 100MG CAPSULE;ORAL Prescription No AB 200463 MYLAN PHARMS INC
ITRACONAZOLE ITRACONAZOLE 100MG CAPSULE;ORAL Prescription No AB 205724 PAR PHARM INC
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English