Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016765
Company: ELORAC
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. |
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| 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. |