Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022160
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
04/20/2016 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
04/20/2016 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 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 PHARM CO LTD
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 PHARM CO LTD
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

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