Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040258
Company: FRESENIUS KABI USA

Products on ANDA 040258

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM	EQ 200MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040258

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/26/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40258ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/29/2011	SUPPL-6	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 040258

LEUCOVORIN CALCIUM PRESERVATIVE FREE

INJECTABLE;INJECTION; EQ 200MG 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 200MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	217021	HAINAN POLY
LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 200MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	216590	KINDOS
LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM	EQ 200MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	040258	FRESENIUS KABI USA
LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM	EQ 200MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	040056	HIKMA
LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM	EQ 200MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	203800	MYLAN LABS LTD
LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM	EQ 200MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	200753	SAGENT PHARMS