NDA 17481, held by Janssen Pharms. Mebendazole.
As of Nov 13, 2026, NDA 17481 (Vermox), held by Janssen Pharms, was first approved by FDA on Jun 28, 1974, with 37 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 28, 1974 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vermox100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, chewable;oral | Mebendazole | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 13, 2017 | Supplement 47Labeling · Standard review | Approved | |
| Oct 20, 1998 | Supplement 45Manufacturing · Priority review | Approved | None posted |
| Jul 27, 1998 | Supplement 44Manufacturing · Priority review | Approved | None posted |
| May 20, 1998 | Supplement 43Manufacturing · Priority review | Approved | None posted |
| Mar 20, 1998 | Supplement 42Manufacturing · Priority review | Approved | None posted |
| Feb 13, 1998 | Supplement 38Labeling · Standard review | Approved | None posted |
| Sep 27, 1995 | Supplement 41Manufacturing · Priority review | Approved | None posted |
| Jun 16, 1994 | Supplement 40Manufacturing · Priority review | Approved | None posted |
| Dec 23, 1993 | Supplement 37Manufacturing · Priority review | Approved | None posted |
| Jan 28, 1993 | Supplement 36Manufacturing · Priority review | Approved | None posted |
| Jan 28, 1993 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Sep 28, 1989 | Supplement 34Labeling | Approved | None posted |
| Jan 26, 1986 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Aug 31, 1984 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Aug 9, 1984 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| May 14, 1984 | Supplement 28Labeling | Approved | None posted |
| Jul 11, 1983 | Supplement 25Labeling | Approved | None posted |
| Mar 16, 1983 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Mar 16, 1983 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Jun 4, 1981 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Dec 29, 1980 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Apr 3, 1980 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Apr 1, 1980 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Apr 1, 1980 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Sep 13, 1979 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Mar 8, 1979 | Supplement 16Labeling | Approved | None posted |
| Mar 8, 1979 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Feb 15, 1979 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Oct 27, 1978 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Apr 24, 1978 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Aug 24, 1977 | Supplement 9Labeling | Approved | None posted |
| Jul 29, 1977 | Supplement 8Labeling | Approved | None posted |
| Mar 4, 1977 | Supplement 7Labeling | Approved | None posted |
| Mar 18, 1976 | Supplement 6Labeling | Approved | None posted |
| Mar 18, 1976 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Oct 30, 1975 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Oct 30, 1975 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Jun 28, 1974 | 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
