Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016267
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESFERAL DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
DESFERAL DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/01/1968 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/27/2016 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

06/14/2013 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

12/16/2011 SUPPL-50 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016267s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016267s050ltr.pdf
09/07/2010 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016267s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016267s047ltr.pdf
01/28/2009 SUPPL-45 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016267s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016267s045ltr.pdf
01/19/2007 SUPPL-44 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016267s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016267s044ltr.pdf
01/15/2002 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

02/14/2002 SUPPL-39 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16267s39ltr.pdf
07/05/2001 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/2002 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

01/05/2001 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/2000 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

04/09/2001 SUPPL-34 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16267S34ltr.pdf
05/25/2000 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/23/1998 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

12/22/1998 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

12/22/1998 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/22/1998 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/02/1997 SUPPL-28 Labeling

Label is not available on this site.

06/19/1995 SUPPL-27 Labeling

Label is not available on this site.

08/31/1994 SUPPL-26 Labeling

Label is not available on this site.

01/30/1998 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

01/30/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/12/1990 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/08/1987 SUPPL-21 Labeling

Label is not available on this site.

02/13/1987 SUPPL-20 Labeling

Label is not available on this site.

09/27/1985 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/1986 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

01/04/1984 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/06/1984 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/1986 SUPPL-15 Labeling

Label is not available on this site.

09/02/1980 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/08/1980 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/04/1979 SUPPL-12 Labeling

Label is not available on this site.

06/04/1979 SUPPL-11 Efficacy

Label is not available on this site.

04/06/1978 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/25/1978 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1977 SUPPL-8 Unspecified

Label is not available on this site.

01/20/1976 SUPPL-7 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/16/2011 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016267s050lbl.pdf
09/07/2010 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016267s047lbl.pdf
01/28/2009 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016267s045lbl.pdf
01/19/2007 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016267s044lbl.pdf

DESFERAL

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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