Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022160
Company: TEVA PHARMS
Company: TEVA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXALIPLATIN | OXALIPLATIN | 50MG/10ML (5MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | AP | Yes | Yes |
OXALIPLATIN | OXALIPLATIN | 100MG/20ML (5MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/07/2009 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Letter (PDF)
Review Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022160s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022160_oxaliplatin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022160s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/10/2020 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022160s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022160Orig1s012ltr.pdf | |
04/20/2016 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022160s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022160Orig1s010ltr.pdf | |
11/25/2013 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022160s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022160Orig1s009ltr.pdf | |
11/25/2013 | SUPPL-8 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022160Orig1s008ltr.pdf |
11/20/2012 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/10/2012 | SUPPL-4 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022160s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022160Orig1s004ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/10/2020 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022160s012lbl.pdf | |
04/20/2016 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022160s010lbl.pdf | |
11/25/2013 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022160s009lbl.pdf | |
08/10/2012 | SUPPL-4 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022160s004lbl.pdf |
OXALIPLATIN
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 |
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 |
OXALIPLATIN | OXALIPLATIN | 50MG/10ML (5MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203869 | HENGRUI PHARMA |
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 | 217348 | KINDOS |
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 | 207562 | NOVAST LABS |
OXALIPLATIN | OXALIPLATIN | 50MG/10ML (5MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204368 | QILU PHARM HAINAN |
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 |
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 |
OXALIPLATIN | OXALIPLATIN | 100MG/20ML (5MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203869 | HENGRUI PHARMA |
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 | 217348 | KINDOS |
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 | 207562 | NOVAST LABS |
OXALIPLATIN | OXALIPLATIN | 100MG/20ML (5MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204368 | QILU PHARM HAINAN |
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 |