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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076019
Company: HOSPIRA

Products on ANDA 076019

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076019

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/17/2004	ORIG-1	Approval			Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076019_s000_DeferoxamineTOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/08/2025	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
10/23/2023	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
10/23/2023	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
11/08/2016	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
12/03/2009	SUPPL-11	Labeling		Label is not available on this site.
12/14/2007	SUPPL-8	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076019

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
DEFEROXAMINE MESYLATE	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	076019	HOSPIRA
DESFERAL	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	016267	MITEM PHARMA

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
DEFEROXAMINE MESYLATE	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	076019	HOSPIRA

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