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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207474
Company: ACCORD HLTHCARE

Products on ANDA 207474

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXALIPLATIN	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No
OXALIPLATIN	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No
OXALIPLATIN	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207474

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/21/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/08/2022	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207474

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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