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): 078718
Company: FRESENIUS KABI USA

Products on ANDA 078718

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEFEROXAMINE MESYLATE	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No
DEFEROXAMINE MESYLATE	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078718

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/15/2009	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
11/28/2023	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
07/18/2012	SUPPL-6	Labeling-Container/Carton Labels		Label is not available on this site.
06/20/2012	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
05/27/2011	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078718

DEFEROXAMINE MESYLATE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFEROXAMINE MESYLATE	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	078718	FRESENIUS KABI USA
DEFEROXAMINE MESYLATE	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	207384	GLAND PHARMA LTD
DEFEROXAMINE MESYLATE	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	076019	HOSPIRA
DEFEROXAMINE MESYLATE	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	078086	WEST-WARD PHARMS INT
DESFERAL	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	016267	NOVARTIS

INJECTABLE;INJECTION; 2GM/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFEROXAMINE MESYLATE	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	078718	FRESENIUS KABI USA
DEFEROXAMINE MESYLATE	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	207384	GLAND PHARMA LTD
DEFEROXAMINE MESYLATE	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	076019	HOSPIRA
DEFEROXAMINE MESYLATE	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	078086	WEST-WARD PHARMS INT

Top