Documents
Application Sponsors
| NDA 021759 | SANOFI AVENTIS US | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Discontinued | 003 |
Application Products
| 001 | INJECTABLE;INTRAVENOUS | 50MG/10ML (5MG/ML) | 1 | ELOXATIN | OXALIPLATIN |
| 002 | INJECTABLE;INTRAVENOUS | 100MG/20ML (5MG/ML) | 1 | ELOXATIN | OXALIPLATIN |
| 003 | INJECTABLE;INTRAVENOUS | 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ELOXATIN | OXALIPLATIN |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2005-01-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2006-11-17 | N/A |
| LABELING; Labeling | SUPPL | 8 | AP | 2008-05-21 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2009-03-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2009-07-22 | N/A |
| LABELING; Labeling | SUPPL | 12 | AP | 2011-12-28 | UNKNOWN |
| LABELING; Labeling | SUPPL | 15 | AP | 2012-10-12 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2013-07-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2013-11-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2015-01-20 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2015-10-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2016-12-09 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2020-04-06 | STANDARD |
Submissions Property Types
| SUPPL | 12 | Null | 15 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 15 |
| SUPPL | 23 | Null | 6 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 21759
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"ELOXATIN","activeIngredients":"OXALIPLATIN","strength":"50MG\/10ML (5MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ELOXATIN","activeIngredients":"OXALIPLATIN","strength":"100MG\/20ML (5MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ELOXATIN","activeIngredients":"OXALIPLATIN","strength":"200MG\/40ML (5MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]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-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021759s023lbl.pdf\"}]","notes":""},{"actionDate":"10\/01\/2015","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021759s019lbledt.pdf\"}]","notes":""},{"actionDate":"07\/16\/2013","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021759s016lbl.pdf\"}]","notes":""},{"actionDate":"10\/12\/2012","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021759s015lbl.pdf\"}]","notes":""},{"actionDate":"12\/28\/2011","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021759s012lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2009","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021492s011,021759s009lbl.pdf\"}]","notes":""},{"actionDate":"03\/09\/2006","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021759s001,021492s006lbl.pdf\"}]","notes":""},{"actionDate":"01\/31\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021759lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ELOXATIN","submission":"OXALIPLATIN","actionType":"50MG\/10ML (5MG\/ML)","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ELOXATIN","submission":"OXALIPLATIN","actionType":"100MG\/20ML (5MG\/ML)","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ELOXATIN","submission":"OXALIPLATIN","actionType":"200MG\/40ML (5MG\/ML) **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
)
)