Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021759
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ELOXATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription AP Yes Yes
ELOXATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription AP Yes Yes
ELOXATIN OXALIPLATIN 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INTRAVENOUS Discontinued None Yes No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
01/31/2005 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021759lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021759ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021759s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/06/2020 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021759s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021759Orig1s023ltr.pdf
12/09/2016 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/01/2015 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021759s019lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021759Orig1s019ltr.pdf
01/20/2015 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/15/2013 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/16/2013 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021759s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021759Orig1s016ltr.pdf
10/12/2012 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021759s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021759Orig1s015ltr.pdf
12/28/2011 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021759s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021492s012,021759s012ltr.pdf
07/22/2009 SUPPL-10 Labeling-Container/Carton Labels

Label is not available on this site.

03/13/2009 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021492s011,021759s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021492s011,021759s009ltr.pdf
05/21/2008 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021492se8_010,021759s008ltr.pdf
11/17/2006 SUPPL-6 Labeling-Container/Carton Labels

Label is not available on this site.

03/09/2006 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021759s001,021492s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021759s001,021492s006ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/06/2020 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021759s023lbl.pdf
10/01/2015 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021759s019lbledt.pdf
07/16/2013 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021759s016lbl.pdf
10/12/2012 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021759s015lbl.pdf
12/28/2011 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021759s012lbl.pdf
03/13/2009 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021492s011,021759s009lbl.pdf
03/09/2006 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021759s001,021492s006lbl.pdf
01/31/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021759lbl.pdf

ELOXATIN

INJECTABLE;INTRAVENOUS; 50MG/10ML (5MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ELOXATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription Yes AP 021759 SANOFI AVENTIS US
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207474 ACCORD HLTHCARE
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204880 ACTAVIS LLC
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 208523 CIPLA
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 205529 EUGIA PHARMA
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 078811 FRESENIUS KABI USA
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 090030 FRESENIUS KABI USA
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207325 GLAND PHARMA LTD
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 078813 HOSPIRA WORLDWIDE
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207562 INGENUS PHARMS LLC
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 203869 JIANGSU HENGRUI MED
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 091358 MYLAN LABS LTD
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204368 QILU
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 078817 SANDOZ
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription Yes AP 022160 TEVA PHARMS

INJECTABLE;INTRAVENOUS; 100MG/20ML (5MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ELOXATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription Yes AP 021759 SANOFI AVENTIS US
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207474 ACCORD HLTHCARE
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204880 ACTAVIS LLC
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 208523 CIPLA
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 205529 EUGIA PHARMA
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 078811 FRESENIUS KABI USA
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 090030 FRESENIUS KABI USA
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207325 GLAND PHARMA LTD
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 078813 HOSPIRA WORLDWIDE
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207562 INGENUS PHARMS LLC
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 203869 JIANGSU HENGRUI MED
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 091358 MYLAN LABS LTD
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204368 QILU
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 078817 SANDOZ
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription Yes AP 022160 TEVA PHARMS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English