Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021144
Company: SANOFI AVENTIS US

• Medication Guide

• Other Important Information from FDA

Products on NDA 21144

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KETEK	TELITHROMYCIN	400MG	TABLET;ORAL	Discontinued	None	No	No
KETEK	TELITHROMYCIN	300MG	TABLET;ORAL	Discontinued	None	No	No

Labels for NDA 021144

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/04/2015	SUPPL-19	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/2015/021144s019lbl.pdf
11/04/2015	SUPPL-19	Labeling-Medication Guide	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/2015/021144s019lbl.pdf
03/09/2015	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021144s018lbl.pdf
12/08/2010	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021144s014lbl.pdf
12/08/2010	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021144s013lbl.pdf
02/12/2007	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021144s012lbl.pdf
06/29/2006	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021144s011lbl.pdf
11/02/2005	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021144s004lbl.pdf
02/09/2005	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21144s001,003lbl.pdf
02/09/2005	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21144s001,003lbl.pdf
04/01/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21144_ketek_lbl.pdf