Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 050686
Company: BURKE THERAP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEDAX	CEFTIBUTEN DIHYDRATE	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No
CEDAX	CEFTIBUTEN DIHYDRATE	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/11/2011	SUPPL-16	Manufacturing (CMC)	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050686s016lbl.pdf
02/10/2009	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050685s011,050686s014lbl.pdf