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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078803
Company: ACTAVIS TOTOWA

Products on ANDA 078803

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXALIPLATIN	OXALIPLATIN	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	AP	No	Yes
OXALIPLATIN	OXALIPLATIN	100MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078803

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/08/2012	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
11/29/2023	SUPPL-7	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
12/31/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
12/31/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
03/20/2013	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078803

OXALIPLATIN

INJECTABLE;INTRAVENOUS; 50MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXALIPLATIN	OXALIPLATIN	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	078803	ACTAVIS TOTOWA
OXALIPLATIN	OXALIPLATIN	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	078819	FRESENIUS KABI USA
OXALIPLATIN	OXALIPLATIN	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	207385	GLAND PHARMA LTD
OXALIPLATIN	OXALIPLATIN	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204616	QILU PHARM HAINAN

INJECTABLE;INTRAVENOUS; 100MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXALIPLATIN	OXALIPLATIN	100MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	078803	ACTAVIS TOTOWA
OXALIPLATIN	OXALIPLATIN	100MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	078819	FRESENIUS KABI USA
OXALIPLATIN	OXALIPLATIN	100MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	207385	GLAND PHARMA LTD
OXALIPLATIN	OXALIPLATIN	100MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204616	QILU PHARM HAINAN

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