NDA 18768, held by Corden Pharma. Etoposide.
As of Nov 13, 2026, NDA 18768 (Vepesid), held by Corden Pharma, was first approved by FDA on Nov 10, 1983, with 35 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 4, 1986 | Supplement 7Efficacy (new indication or use) | Approved | None posted |
| Nov 10, 1983 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vepesid20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Etoposide | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 5, 2002 | Supplement 45Labeling · Standard review | Approved | |
| Oct 25, 2000 | Supplement 46Manufacturing · Priority review | Approved | None posted |
| Feb 2, 2000 | Supplement 44Manufacturing · Priority review | Approved | None posted |
| Apr 2, 1999 | Supplement 41Labeling · Standard review | Approved | |
| Dec 15, 1998 | Supplement 40Manufacturing · Priority review | Approved | None posted |
| Dec 11, 1995 | Supplement 37Manufacturing · Priority review | Approved | None posted |
| Aug 8, 1995 | Supplement 36Manufacturing · Priority review | Approved | None posted |
| Jun 27, 1995 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| May 17, 1995 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Dec 20, 1993 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| Aug 30, 1993 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Aug 24, 1993 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Jul 23, 1993 | Supplement 30Labeling · Standard review | Approved | None posted |
| Nov 1, 1991 | Supplement 26Labeling | Approved | None posted |
| Nov 1, 1991 | Supplement 25Labeling | Approved | None posted |
| Sep 4, 1990 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Apr 4, 1990 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Apr 10, 1989 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Apr 28, 1988 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Feb 11, 1988 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Jan 25, 1988 | Supplement 17Labeling | Approved | None posted |
| May 20, 1987 | Supplement 16Labeling | Approved | None posted |
| Mar 19, 1987 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Dec 22, 1986 | Supplement 13Labeling | Approved | None posted |
| Nov 6, 1986 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Oct 29, 1986 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Sep 4, 1986 | Supplement 7Efficacy (new indication or use) | Approved | None posted |
| Aug 26, 1986 | Supplement 10Labeling | Approved | None posted |
| Jun 30, 1986 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Mar 12, 1985 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Mar 6, 1985 | Supplement 5Labeling | Approved | None posted |
| Mar 6, 1985 | Supplement 4Labeling | Approved | None posted |
| Mar 6, 1985 | Supplement 3Labeling | Approved | None posted |
| Mar 6, 1985 | Supplement 2Labeling | Approved | None posted |
| Aug 21, 1984 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Nov 10, 1983 | Original applicationNew molecular entity · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
