Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 050675
Company: PFIZER

Products on NDA 50675

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VANTIN	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No
VANTIN	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No

Labels for NDA 050675

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/21/2013	SUPPL-18	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/2013/050674s015,050675s018lbl.pdf
06/05/2007	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050674s014,050675s017lbl.pdf
06/02/2004	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50675slr013,016_vantin_lbl.pdf