Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078718
Company: FRESENIUS KABI USA
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
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
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.

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
DESFERAL DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE;INJECTION Prescription Yes AP 016267 NOVARTIS

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