Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020657
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
03/08/2019 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
03/08/2019 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

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