Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016765
Company: ELORAC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOROPLEX FLUOROURACIL 1% SOLUTION;TOPICAL 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
07/31/1970 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/30/1998 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/30/1997 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/1992 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

11/12/1986 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/13/1982 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

08/16/1982 SUPPL-22 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/28/1987 SUPPL-21 Labeling

Label is not available on this site.

05/15/1981 SUPPL-20 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/13/1982 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/12/1981 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/18/1980 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1979 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1979 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/1978 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/15/1977 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/03/1976 SUPPL-11 Labeling

Label is not available on this site.

07/01/1976 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

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