Documents
Application Sponsors
| NDA 021492 | SANOFI AVENTIS US | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INTRAVENOUS | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ELOXATIN | OXALIPLATIN |
| 002 | INJECTABLE;INTRAVENOUS | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ELOXATIN | OXALIPLATIN |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2002-08-09 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2004-01-09 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2004-11-04 | UNKNOWN |
| LABELING; Labeling | SUPPL | 5 | AP | 2004-11-04 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2006-03-09 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2007-01-10 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2008-05-21 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2009-03-13 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2011-12-28 | UNKNOWN |
| LABELING; Labeling | SUPPL | 13 | AP | 2012-10-12 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2015-10-01 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2020-04-06 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 2 |
| SUPPL | 2 | Null | 31 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 10 | Null | 6 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 16 | Null | 15 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 21492
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"ELOXATIN","activeIngredients":"OXALIPLATIN","strength":"50MG\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ELOXATIN","activeIngredients":"OXALIPLATIN","strength":"100MG\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"04\/06\/2020","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021492s016lbl.pdf\"}]","notes":""},{"actionDate":"10\/01\/2015","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021492s014lbl.pdf\"}]","notes":""},{"actionDate":"10\/12\/2012","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021492s013lbl.pdf\"}]","notes":""},{"actionDate":"12\/28\/2011","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021492s012lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2009","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021492s011,021759s009lbl.pdf\"}]","notes":""},{"actionDate":"01\/10\/2007","submission":"SUPPL-8","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021492s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/09\/2006","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021759s001,021492s006lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2004","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/021492s004lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2004","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/021492s004lbl.pdf\"}]","notes":""},{"actionDate":"01\/09\/2004","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21492se1-002_eloxatin_lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21492lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ELOXATIN","submission":"OXALIPLATIN","actionType":"50MG\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ELOXATIN","submission":"OXALIPLATIN","actionType":"100MG\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-04-06
)
)