Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021222
Company: VANSEN PHARMA

Products on NDA 21222

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SPECTRACEF	CEFDITOREN PIVOXIL	200MG	TABLET;ORAL	Discontinued	None	No	No
SPECTRACEF	CEFDITOREN PIVOXIL	400MG	TABLET;ORAL	Discontinued	None	No	No

Labels for NDA 021222

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/06/2012	SUPPL-16	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/2012/021222s013s016lbl.pdf
08/06/2012	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021222s013s016lbl.pdf
07/21/2008	SUPPL-12	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021222s012lbl.pdf
12/20/2005	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021222s009lbl.pdf
08/21/2002	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21222s1lbl.pdf
08/29/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21222lbl.pdf