Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207385
Company: GLAND

Products on ANDA 207385

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207385

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/23/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 207385

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	078819	FRESENIUS KABI USA
OXALIPLATIN	OXALIPLATIN	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	207385	GLAND
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	078819	FRESENIUS KABI USA
OXALIPLATIN	OXALIPLATIN	100MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	207385	GLAND
OXALIPLATIN	OXALIPLATIN	100MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204616	QILU PHARM HAINAN