Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 050621
Company: LEDERLE

Products on NDA 50621

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUPRAX	CEFIXIME	200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
SUPRAX	CEFIXIME	400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Labels for NDA 050621

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/29/2004	SUPPL-23	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50621slr023,50622slr017_suprax_lbl.pdf
08/20/2003	SUPPL-26	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50621slr026,50622slr020_suprax_lbl.pdf