Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020966
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

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