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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 021144

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021144

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/01/2004	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21144_ketek_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21144ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-144_Ketek.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/04/2015	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021144Orig1s019ltr.pdf
03/09/2015	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021144s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021144Orig1s018ltr.pdf
02/26/2014	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
07/11/2013	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
06/20/2011	SUPPL-15	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021144s015ltr.pdf
12/08/2010	SUPPL-14	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021144s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021144s013,s014ltr.pdf
12/08/2010	SUPPL-13	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021144s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021144s013,s014ltr.pdf
02/12/2007	SUPPL-12	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021144s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021144s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021144Orig1s012Approv.pdf
06/29/2006	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021144s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021144s011ltr.pdf
04/08/2005	SUPPL-5	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21144s005ltr.pdf
11/02/2005	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021144s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021144s004ltr.pdf
02/09/2005	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21144s001,003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21144s001,003ltr.pdf
02/09/2005	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21144s001,003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21144s001,003ltr.pdf

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

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