An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040056
Company: HIKMA

Products on ANDA 040056

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040056

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/23/1995	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
01/17/2012	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040347s010lbl.pdf
12/21/2000	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
08/03/1998	SUPPL-3	Labeling		Label is not available on this site.
02/24/1998	SUPPL-2	Labeling		Label is not available on this site.
05/31/1996	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 040056

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/17/2012	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040347s010lbl.pdf

Therapeutic Equivalents for ANDA 040056

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

Top