Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050685
Company: SI PHARMS

Products on NDA 50685

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEDAX	CEFTIBUTEN DIHYDRATE	EQ 400MG BASE	CAPSULE;ORAL	Discontinued	None	No	No

Labels for NDA 050685

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/10/2009	SUPPL-11	Labeling	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/2009/050685s011,050686s014lbl.pdf