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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020966
Company: JANSSEN PHARMS

Products on NDA 020966

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SPORANOX	ITRACONAZOLE	10MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020966

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

Labels for NDA 020966

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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