NDA 17694, held by J And J Consumer Inc. Loperamide Hydrochloride.
As of Nov 13, 2026, NDA 17694 (Imodium), held by J And J Consumer Inc, was first approved by FDA on Dec 28, 1976, with 46 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 28, 1976 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Imodium2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Loperamide Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 3, 2016 | Supplement 52Labeling · Standard review | Approved | |
| Oct 21, 2005 | Supplement 50Labeling · Standard review | Approved | |
| Oct 13, 1999 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Jun 17, 1999 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1999 | Supplement 47Labeling · Standard review | Approved | None posted |
| Sep 1, 1998 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Jun 30, 1998 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Jun 2, 1998 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Oct 5, 1995 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Aug 24, 1993 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Jun 1, 1993 | Supplement 41Labeling · Standard review | Approved | None posted |
| Oct 2, 1992 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| May 26, 1988 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Apr 15, 1988 | Supplement 37Labeling | Approved | None posted |
| Jun 16, 1987 | Supplement 35Labeling | Approved | None posted |
| Sep 16, 1986 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1985 | Supplement 32Labeling | Approved | None posted |
| Sep 20, 1985 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Aug 2, 1984 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Aug 2, 1984 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1984 | Supplement 19Labeling | Approved | None posted |
| Nov 22, 1983 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Jul 15, 1983 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Apr 27, 1983 | Supplement 22Labeling | Approved | None posted |
| Feb 15, 1983 | Supplement 27Labeling | Approved | None posted |
| Dec 15, 1982 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Nov 3, 1982 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Nov 3, 1982 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Aug 10, 1982 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| May 19, 1982 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| May 14, 1981 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| May 11, 1981 | Supplement 17Labeling | Approved | None posted |
| Jun 13, 1980 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Mar 26, 1980 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Nov 5, 1979 | Supplement 14Labeling | Approved | None posted |
| Oct 3, 1979 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jun 25, 1979 | Supplement 11Labeling | Approved | None posted |
| May 23, 1979 | Supplement 12Labeling | Approved | None posted |
| Apr 5, 1979 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Apr 5, 1979 | Supplement 9Labeling | Approved | None posted |
| Mar 14, 1979 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Oct 30, 1978 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Oct 30, 1978 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Sep 14, 1978 | Supplement 1Labeling | Approved | None posted |
| Jul 5, 1978 | Supplement 5Labeling | Approved | None posted |
| Apr 24, 1978 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Dec 28, 1976 | Original applicationNew molecular entity · Standard 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
