Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218200
Company: GLAND

Products on ANDA 218200

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 350MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218200

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/12/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218200

LEUCOVORIN CALCIUM

INJECTABLE;INJECTION; EQ 350MG 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 350MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	218200	GLAND
LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 350MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	217021	HAINAN POLY
LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 350MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	216590	MEITHEAL
LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM	EQ 350MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	040335	HIKMA
LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM	EQ 350MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	203800	MYLAN LABS LTD
LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM	EQ 350MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	200855	SAGENT PHARMS