Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 010787
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IRON DEXTRAN 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
04/25/1957 ORIG-1 Approval Type 2 - New Active Ingredient 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
09/19/1991 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

03/06/1989 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1988 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1987 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1986 SUPPL-23 Labeling

Label is not available on this site.

11/20/1984 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

12/20/1983 SUPPL-21 Labeling

Label is not available on this site.

12/29/1982 SUPPL-19 Labeling

Label is not available on this site.

06/23/1982 SUPPL-17 Labeling

Label is not available on this site.

08/18/1982 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

09/04/1981 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/02/1981 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/13/1980 SUPPL-13 Labeling

Label is not available on this site.

11/12/1976 SUPPL-12 Labeling

Label is not available on this site.

11/04/1976 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

11/18/1975 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

01/06/1981 SUPPL-9 Unspecified

Label is not available on this site.

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