Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021144
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
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 |
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 |
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 |