Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204368
Company: QILU PHARM HAINAN

Products on ANDA 204368

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	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204368

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/07/2016	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/11/2023	SUPPL-16	Labeling-Patient Package Insert		Label is not available on this site.
11/17/2021	SUPPL-5	Labeling-Container/Carton Labels		Label is not available on this site.
11/17/2021	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204368

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
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	078811	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	217925	HETERO LABS LTD VI
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	MEITHEAL
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 HAINAN
OXALIPLATIN	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	078817	SANDOZ
OXALIPLATIN	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	219765	SHANDONG

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
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	078811	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	217925	HETERO LABS LTD VI
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	MEITHEAL
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 HAINAN
OXALIPLATIN	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	078817	SANDOZ
OXALIPLATIN	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	219765	SHANDONG