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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209110
Company: SAGENT PHARMS INC

Products on ANDA 209110

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209110

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/26/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209110

LEUCOVORIN CALCIUM PRESERVATIVE FREE

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	217021	HAINAN POLY
LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	216590	MEITHEAL
LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	040286	FRESENIUS KABI USA
LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	209110	SAGENT PHARMS INC

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