NDA 50429, held by Tp Anda Holdings. Rifampin.
As of Nov 14, 2026, NDA 50429 (Rimactane), held by Tp Anda Holdings, was first approved by FDA on May 21, 1971, with 83 approved supplements and 0 published complete response letters.
| May 18, 1976 | Supplement 42Efficacy (new indication or use) | Approved | None posted |
| May 9, 1973 | Supplement 29Efficacy (new indication or use) | Approved | None posted |
| May 21, 1971 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rimactane300MG · capsule;oral | Rifampin | Rx |
| Aug 12, 2026 | Supplement 88Labeling · Standard review | Approved | |
| Aug 16, 2023 | Supplement 87Labeling · Standard review | Approved | |
| Jan 23, 2019 | Supplement 86Labeling · Standard review | Approved | |
| Nov 18, 2004 | Supplement 83Labeling · Standard review | Approved | |
| Mar 1, 2001 | Supplement 81Manufacturing | Approved | None posted |
| May 26, 2000 | Supplement 80Manufacturing | Approved | None posted |
| May 26, 2000 | Supplement 79Manufacturing | Approved | None posted |
| Feb 18, 1999 | Supplement 78Manufacturing | Approved | None posted |
| Oct 30, 1998 | Supplement 77Manufacturing | Approved | None posted |
| Aug 14, 1998 | Supplement 76Manufacturing | Approved | None posted |
| Apr 7, 1997 | Supplement 75Manufacturing | Approved | None posted |
| Mar 4, 1996 | Supplement 74Manufacturing | Approved | None posted |
| Mar 27, 1995 | Supplement 73Manufacturing | Approved | None posted |
| Jul 29, 1994 | Supplement 71Manufacturing | Approved | None posted |
| Jun 6, 1994 | Supplement 72Manufacturing | Approved | None posted |
| Sep 23, 1992 | Supplement 70Manufacturing | Approved | None posted |
| Aug 24, 1992 | Supplement 69Manufacturing | Approved | None posted |
| Aug 24, 1992 | Supplement 68Manufacturing | Approved | None posted |
| Aug 24, 1992 | Supplement 66Manufacturing | Approved | None posted |
| May 31, 1991 | Supplement 67Manufacturing | Approved | None posted |
| Feb 23, 1990 | Supplement 12Manufacturing | Approved | None posted |
| Jul 21, 1989 | Supplement 11Labeling | Approved | None posted |
| Nov 29, 1988 | Supplement 10Manufacturing | Approved | None posted |
| Nov 29, 1988 | Supplement 9Manufacturing | Approved | None posted |
| Oct 7, 1985 | Supplement 8Labeling | Approved | None posted |
| Jul 8, 1985 | Supplement 7Manufacturing | Approved | None posted |
| May 29, 1985 | Supplement 6Manufacturing | Approved | None posted |
| Apr 3, 1985 | Supplement 5Manufacturing | Approved | None posted |
| Sep 25, 1984 | Supplement 4Manufacturing | Approved | None posted |
| Nov 29, 1983 | Supplement 3Manufacturing | Approved | None posted |
| Sep 13, 1983 | Supplement 2Manufacturing | Approved | None posted |
| Dec 6, 1982 | Supplement 1Manufacturing | Approved | None posted |
| Sep 28, 1982 | Supplement 65Manufacturing | Approved | None posted |
| Jun 17, 1982 | Supplement 64Manufacturing | Approved | None posted |
| Dec 10, 1981 | Supplement 63Manufacturing | Approved | None posted |
| Mar 23, 1981 | Supplement 62Manufacturing | Approved | None posted |
| Jul 2, 1980 | Supplement 61Manufacturing | Approved | None posted |
| Oct 29, 1979 | Supplement 60Manufacturing | Approved | None posted |
| Aug 21, 1979 | Supplement 59Manufacturing | Approved | None posted |
| Apr 13, 1979 | Supplement 58Manufacturing | Approved | None posted |
| Jan 22, 1979 | Supplement 57Manufacturing | Approved | None posted |
| Jun 12, 1978 | Supplement 55Labeling | Approved | None posted |
| May 5, 1978 | Supplement 53Labeling | Approved | None posted |
| Feb 1, 1978 | Supplement 52Manufacturing | Approved | None posted |
| Sep 27, 1977 | Supplement 51Manufacturing | Approved | None posted |
| Jun 21, 1977 | Supplement 50Labeling | Approved | None posted |
| Jun 14, 1977 | Supplement 49Manufacturing | Approved | None posted |
| Jun 1, 1977 | Supplement 48Manufacturing | Approved | None posted |
| May 31, 1977 | Supplement 47Labeling | Approved | None posted |
| Feb 18, 1977 | Supplement 46Labeling | Approved | None posted |
| Sep 14, 1976 | Supplement 45Labeling | Approved | None posted |
| Jul 21, 1976 | Supplement 44Manufacturing | Approved | None posted |
| May 26, 1976 | Supplement 43Manufacturing | Approved | None posted |
| May 18, 1976 | Supplement 42Efficacy (new indication or use) | Approved | None posted |
| Mar 26, 1976 | Supplement 41Manufacturing | Approved | None posted |
| Dec 9, 1975 | Supplement 40Manufacturing | Approved | None posted |
| Aug 22, 1975 | Supplement 39Manufacturing | Approved | None posted |
| Dec 9, 1974 | Supplement 38Manufacturing | Approved | None posted |
| Sep 30, 1974 | Supplement 37Manufacturing | Approved | None posted |
| Sep 18, 1974 | Supplement 36Manufacturing | Approved | None posted |
| Mar 28, 1974 | Supplement 35Manufacturing | Approved | None posted |
| Jan 24, 1974 | Supplement 34Labeling | Approved | None posted |
| Jan 16, 1974 | Supplement 33Manufacturing | Approved | None posted |
| Dec 4, 1973 | Supplement 32Labeling | Approved | None posted |
| Oct 26, 1973 | Supplement 28Manufacturing | Approved | None posted |
| Oct 9, 1973 | Supplement 31Labeling | Approved | None posted |
| Oct 4, 1973 | Supplement 30Labeling | Approved | None posted |
| Oct 4, 1973 | Supplement 27Labeling | Approved | None posted |
| May 9, 1973 | Supplement 29Efficacy (new indication or use) | Approved | None posted |
| Jan 30, 1973 | Supplement 26Manufacturing | Approved | None posted |
| Jan 5, 1973 | Supplement 25Labeling | Approved | None posted |
| Oct 3, 1972 | Supplement 24Labeling | Approved | None posted |
| Aug 10, 1972 | Supplement 23Manufacturing | Approved | None posted |
| Jul 14, 1972 | Supplement 22Manufacturing | Approved | None posted |
| Jun 29, 1972 | Supplement 21Manufacturing | Approved | None posted |
| May 17, 1972 | Supplement 20Manufacturing | Approved | None posted |
| Apr 13, 1972 | Supplement 19Manufacturing | Approved | None posted |
| Feb 22, 1972 | Supplement 18Manufacturing | Approved | None posted |
| Jan 14, 1972 | Supplement 17Manufacturing | Approved | None posted |
| Aug 13, 1971 | Supplement 16Manufacturing | Approved | None posted |
| Aug 6, 1971 | Supplement 15Manufacturing | Approved | None posted |
| Jun 28, 1971 | Supplement 14Labeling | Approved | None posted |
| May 24, 1971 | Supplement 13Manufacturing | Approved | None posted |
| May 21, 1971 | Original application | 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
