Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016831
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EFUDEX FLUOROURACIL 2% SOLUTION;TOPICAL Prescription AT Yes Yes
EFUDEX FLUOROURACIL 5% SOLUTION;TOPICAL Prescription AT Yes Yes
EFUDEX FLUOROURACIL 5% CREAM;TOPICAL Prescription AB 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
07/29/1970 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
11/04/2015 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

08/18/2015 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

05/06/2015 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

07/02/2013 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

12/12/2013 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

05/10/2006 SUPPL-51 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016831s051ltr.pdf
10/13/2005 SUPPL-49 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016831s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016831s049ltr.pdf
06/24/2004 SUPPL-47 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16831slr047_efudex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16831slr047ltr.pdf
04/27/2004 SUPPL-46 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16831scm046ltr.pdf
11/27/2002 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

08/30/2001 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

07/03/2001 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/2001 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/2001 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

06/20/2000 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/2000 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

07/07/2000 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

04/05/2000 SUPPL-35 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/16831_s035_efudex.pdf
11/02/1998 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/1997 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

08/05/1993 SUPPL-31 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/16831_s031_efudex.pdf
03/04/1993 SUPPL-30 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/16831_s030_efudex.pdf
03/21/1995 SUPPL-29 Labeling

Label is not available on this site.

11/30/1988 SUPPL-28 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/16831_s028_efudex.pdf
11/14/1986 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/10/1985 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/14/1985 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/1984 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/1984 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

08/12/1983 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

08/12/1983 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/1983 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

05/14/1982 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

03/10/1982 SUPPL-18 Labeling

Label is not available on this site.

03/26/1987 SUPPL-17 Labeling

Label is not available on this site.

12/18/1979 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1979 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

11/21/1978 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/14/1977 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1977 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1975 SUPPL-11 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/16831_s011_efudex.pdf
05/07/1975 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/1974 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/30/1975 SUPPL-8 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/16831_s008_efudex.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/13/2005 SUPPL-49 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016831s049lbl.pdf
06/24/2004 SUPPL-47 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16831slr047_efudex_lbl.pdf

EFUDEX

SOLUTION;TOPICAL; 2%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EFUDEX FLUOROURACIL 2% SOLUTION;TOPICAL Prescription Yes AT 016831 BAUSCH
FLUOROURACIL FLUOROURACIL 2% SOLUTION;TOPICAL Prescription No AT 076526 TARO

SOLUTION;TOPICAL; 5%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EFUDEX FLUOROURACIL 5% SOLUTION;TOPICAL Prescription Yes AT 016831 BAUSCH
FLUOROURACIL FLUOROURACIL 5% SOLUTION;TOPICAL Prescription No AT 076526 TARO

CREAM;TOPICAL; 5%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EFUDEX FLUOROURACIL 5% CREAM;TOPICAL Prescription Yes AB 016831 BAUSCH
FLUOROURACIL FLUOROURACIL 5% CREAM;TOPICAL Prescription No AB 077524 MAYNE PHARMA
FLUOROURACIL FLUOROURACIL 5% CREAM;TOPICAL Prescription No AB 090368 TARO

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