Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016831
Company: EXTROVIS
Company: EXTROVIS
| 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| EFUDEX | FLUOROURACIL | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;TOPICAL | Discontinued | None | Yes | No |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 |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/14/2021 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016831Orig1s063lbl.pdf | |
| 10/14/2021 | SUPPL-63 | Labeling-Container/Carton Labels | 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 |