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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022027
Company: SCHERING

Products on NDA 022027

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NOXAFIL	POSACONAZOLE	40MG/ML	SUSPENSION; ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022027

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/20/2006	ORIG-1	Approval	Type 6 - New Indication (no longer used)	UNKNOWN	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022027s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022027_noxafil_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/21/2012	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022003s011s012,022027s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022003Orig1s011,s012,022027Orig1s002,s003ltr.pdf
06/21/2012	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022003Orig1s011,s012,022027Orig1s002,s003ltr.pdf
09/08/2010	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022003s008,022027s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022003s008,022027s001ltr.pdf

Labels for NDA 022027

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/21/2012	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022003s011s012,022027s002s003lbl.pdf
06/21/2012	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022003Orig1s011,s012,022027Orig1s002,s003ltr.pdf
09/08/2010	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022003s008,022027s001lbl.pdf
10/20/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022027lbl.pdf

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