Documents
Application Sponsors
| NDA 021144 | SANOFI AVENTIS US | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | 400MG | 0 | KETEK | TELITHROMYCIN |
| 002 | TABLET;ORAL | 300MG | 0 | KETEK | TELITHROMYCIN |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2004-04-01 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2005-02-09 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2005-11-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2005-04-08 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2006-06-29 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2007-02-12 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2010-12-08 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2010-12-08 | STANDARD |
| REMS; REMS | SUPPL | 15 | AP | 2011-06-20 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2013-07-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2014-02-26 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2015-03-09 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2015-11-04 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
Submissions Property Types
| SUPPL | 5 | Null | 0 |
| SUPPL | 13 | Null | 6 |
| SUPPL | 14 | Null | 6 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 19 | Null | 6 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 21144
[companyName] => SANOFI AVENTIS US
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2015\/021144s019lbl.pdf#page=29"]
[products] => [{"drugName":"KETEK","activeIngredients":"TELITHROMYCIN","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KETEK","activeIngredients":"TELITHROMYCIN","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"11\/04\/2015","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021144s019lbl.pdf\"}]","notes":"Please see"},{"actionDate":"11\/04\/2015","submission":"SUPPL-19","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021144s019lbl.pdf\"}]","notes":"Please see"},{"actionDate":"03\/09\/2015","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021144s018lbl.pdf\"}]","notes":""},{"actionDate":"12\/08\/2010","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021144s014lbl.pdf\"}]","notes":""},{"actionDate":"12\/08\/2010","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021144s013lbl.pdf\"}]","notes":""},{"actionDate":"02\/12\/2007","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021144s012lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2006","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021144s011lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2005","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021144s004lbl.pdf\"}]","notes":""},{"actionDate":"02\/09\/2005","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/21144s001,003lbl.pdf\"}]","notes":""},{"actionDate":"02\/09\/2005","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/21144s001,003lbl.pdf\"}]","notes":""},{"actionDate":"04\/01\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21144_ketek_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"KETEK","submission":"TELITHROMYCIN","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KETEK","submission":"TELITHROMYCIN","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2015-11-04
)
)