Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 040024
Company: LUITPOLD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXFERRUM IRON DEXTRAN EQ 50MG IRON/ML INJECTABLE;INJECTION Discontinued None 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
02/23/1996 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/18/2016 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/12/2009 SUPPL-22 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/040024s022lbl.pdf
02/08/2002 SUPPL-12 Labeling

Label is not available on this site.

05/31/2001 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

02/18/2000 SUPPL-10 Labeling

Label is not available on this site.

07/20/2000 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/20/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/25/1998 SUPPL-7 Labeling

Label is not available on this site.

09/25/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/25/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/25/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/29/1998 SUPPL-3 Labeling

Label is not available on this site.

01/29/1998 SUPPL-2 Labeling

Label is not available on this site.

09/19/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/12/2009 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/040024s022lbl.pdf

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