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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022160
Company: TEVA PHARMS

Summary Review

Products on NDA 022160

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022160

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

Labels for NDA 022160

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

Therapeutic Equivalents for NDA 022160

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

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