Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016929
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FUDR FLOXURIDINE 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
12/18/1970 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
09/20/1999 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

09/15/1997 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

10/19/1992 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

07/12/1990 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/1990 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/1989 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/1988 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

06/01/1987 SUPPL-20 Labeling

Label is not available on this site.

01/15/1987 SUPPL-19 Labeling

Label is not available on this site.

01/09/1987 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/23/1985 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

05/14/1990 SUPPL-15 Labeling

Label is not available on this site.

08/22/1990 SUPPL-14 Labeling

Label is not available on this site.

04/07/1978 SUPPL-13 Labeling

Label is not available on this site.

01/09/1978 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/15/1977 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/23/1977 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1976 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1976 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

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