Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016988
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUOROPLEX | FLUOROURACIL | 1% | CREAM;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 08/06/1971 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 02/28/2022 | SUPPL-33 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/016988s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/016988Orig1s033ltr.pdf | |
| 07/25/2016 | SUPPL-30 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016988s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016988Orig1s030ltr.pdf | |
| 01/29/2016 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/2016 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/18/2002 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1997 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/08/1992 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/28/1987 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 01/12/1981 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/07/1980 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/18/1980 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/17/1978 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/01/1977 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 03/02/1977 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1976 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/09/1976 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 12/24/1975 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/17/1974 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/28/2022 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/016988s033lbl.pdf | |
| 02/28/2022 | SUPPL-33 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/016988s033lbl.pdf | |
| 02/28/2022 | SUPPL-33 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/016988s033lbl.pdf | |
| 07/25/2016 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016988s030lbl.pdf | |
| 07/25/2016 | SUPPL-30 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016988s030lbl.pdf |