Drugs@FDA: FDA-Approved Drugs
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| EFUDEX | FLUOROURACIL | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;TOPICAL | Discontinued | None | Yes | No |
| 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 |
|---|---|---|---|---|---|
| 10/14/2021 | SUPPL-63 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016831Orig1s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/016831Orig1s063ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 10/14/2021 | SUPPL-63 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016831Orig1s063lbl.pdf | |
| 10/14/2021 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016831Orig1s063lbl.pdf | |
| 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 |
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 | 214845 | ACCORD HLTHCARE |
| FLUOROURACIL | FLUOROURACIL | 5% | CREAM;TOPICAL | Prescription | No | AB | 077524 | DR REDDYS LABS SA |
| FLUOROURACIL | FLUOROURACIL | 5% | CREAM;TOPICAL | Prescription | No | AB | 090368 | TARO |