NDA 50420, held by Sanofi Aventis US. Rifampin.
As of Nov 13, 2026, NDA 50420 (Rifadin), held by Sanofi Aventis US, was first approved by FDA on May 21, 1971, with 87 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 21, 1971 | Original application | Approved |
| Rifadin300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Rifampin | DiscontinuedReference drug |
| Rifadin150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Rifampin | DiscontinuedReference drug |
| Dec 5, 2025 | Supplement 94Labeling · Standard review | Approved | |
| Oct 8, 2025 | Supplement 93Labeling · Standard review | Approved | |
| Oct 10, 2024 | Supplement 92Labeling · Standard review | Approved | |
| Dec 8, 2023 | Supplement 91Labeling · Standard review | Approved | |
| Aug 16, 2023 | Supplement 90Labeling · Standard review | Approved | |
| Feb 17, 2023 | Supplement 89Labeling · Standard review | Approved | |
| Feb 10, 2023 | Supplement 88Labeling · Standard review | Approved | |
| Jan 29, 2022 | Supplement 87Labeling · Standard review | Approved | |
| Oct 21, 2021 | Supplement 86Labeling · Standard review | Approved | |
| Jun 17, 2021 | Supplement 85Labeling · Standard review | Approved | |
| May 12, 2020 | Supplement 84Labeling · Standard review | Approved | |
| Aug 27, 2019 | Supplement 83Labeling · Standard review | Approved | |
| Feb 28, 2019 | Supplement 80Labeling · Standard review | Approved | |
| Jan 23, 2019 | Supplement 78Labeling · Standard review | Approved | |
| Jan 8, 2018 | Supplement 77Labeling · Standard review | Approved | |
| Apr 24, 2017 | Supplement 76Labeling · Standard review | Approved | |
| Feb 27, 2013 | Supplement 75Labeling · Standard review | Approved | |
| Nov 10, 2010 | Supplement 73Labeling · Standard review | Approved | |
| Aug 20, 2004 | Supplement 72Labeling · Standard review | Approved | |
| Apr 12, 2000 | Supplement 70Labeling · Standard review | Approved | None posted |
| Apr 12, 2000 | Supplement 71Labeling · Standard review | Approved | None posted |
| Sep 17, 1996 | Supplement 67Labeling · Standard review | Approved | None posted |
| Jan 5, 1996 | Supplement 64Manufacturing | Approved | None posted |
| Sep 5, 1995 | Supplement 68Manufacturing | Approved | None posted |
| Jul 12, 1994 | Supplement 66Manufacturing | Approved | None posted |
| Jun 18, 1993 | Supplement 63Labeling | Approved | None posted |
| Feb 12, 1990 | Supplement 7Labeling | Approved | None posted |
| Feb 12, 1990 | Supplement 9Manufacturing | Approved | None posted |
| May 18, 1989 | Supplement 13Manufacturing | Approved | None posted |
| Nov 16, 1987 | Supplement 14Manufacturing | Approved | None posted |
| Feb 18, 1986 | Supplement 11Manufacturing | Approved | None posted |
| Sep 12, 1984 | Supplement 12Labeling | Approved | None posted |
| Feb 8, 1984 | Supplement 10Manufacturing | Approved | None posted |
| Sep 2, 1983 | Supplement 8Labeling | Approved | None posted |
| Nov 17, 1982 | Supplement 5Manufacturing | Approved | None posted |
| Nov 15, 1982 | Supplement 3Manufacturing | Approved | None posted |
| Nov 15, 1982 | Supplement 4Manufacturing | Approved | None posted |
| Oct 26, 1982 | Supplement 2Manufacturing | Approved | None posted |
| Oct 5, 1982 | Supplement 1Manufacturing | Approved | None posted |
| Sep 11, 1982 | Supplement 59Manufacturing | Approved | None posted |
| Mar 22, 1982 | Supplement 18Labeling | Approved | None posted |
| Oct 20, 1981 | Supplement 60Labeling | Approved | None posted |
| Oct 20, 1981 | Supplement 61Manufacturing | Approved | None posted |
| Dec 31, 1980 | Supplement 58Manufacturing | Approved | None posted |
| Jul 25, 1980 | Supplement 57Manufacturing | Approved | None posted |
| Oct 29, 1979 | Supplement 56Manufacturing | Approved | None posted |
| Oct 25, 1979 | Supplement 55Manufacturing | Approved | None posted |
| Jul 25, 1979 | Supplement 54Labeling | Approved | None posted |
| Jun 26, 1979 | Supplement 49Labeling | Approved | None posted |
| May 1, 1979 | Supplement 53Labeling | Approved | None posted |
| Apr 16, 1979 | Supplement 51Manufacturing | Approved | None posted |
| Apr 16, 1979 | Supplement 52Labeling | Approved | None posted |
| Mar 23, 1979 | Supplement 50Labeling | Approved | None posted |
| Jun 29, 1978 | Supplement 48Labeling | Approved | None posted |
| May 30, 1978 | Supplement 47Labeling | Approved | None posted |
| Feb 10, 1978 | Supplement 46Labeling | Approved | None posted |
| Jun 29, 1977 | Supplement 45Labeling | Approved | None posted |
| May 25, 1977 | Supplement 6Manufacturing | Approved | None posted |
| Dec 21, 1976 | Supplement 44Labeling | Approved | None posted |
| Aug 9, 1976 | Supplement 43Manufacturing | Approved | None posted |
| Aug 3, 1976 | Supplement 42Manufacturing | Approved | None posted |
| Mar 29, 1976 | Supplement 37Labeling | Approved | None posted |
| Mar 1, 1976 | Supplement 41Manufacturing | Approved | None posted |
| Feb 18, 1976 | Supplement 40Labeling | Approved | None posted |
| Jan 28, 1976 | Supplement 39Labeling | Approved | None posted |
| Jan 19, 1976 | Supplement 38Labeling | Approved | None posted |
| Oct 15, 1975 | Supplement 35Manufacturing | Approved | None posted |
| Sep 16, 1975 | Supplement 34Labeling | Approved | None posted |
| Aug 28, 1975 | Supplement 36Manufacturing | Approved | None posted |
| Jan 30, 1975 | Supplement 33Labeling | Approved | None posted |
| Nov 26, 1974 | Supplement 32Labeling | Approved | None posted |
| May 29, 1974 | Supplement 30Labeling | Approved | None posted |
| May 21, 1974 | Supplement 31Labeling | Approved | None posted |
| Mar 28, 1974 | Supplement 28Labeling | Approved | None posted |
| Mar 28, 1974 | Supplement 29Manufacturing | Approved | None posted |
| Jan 24, 1974 | Supplement 27Labeling | Approved | None posted |
| Nov 20, 1973 | Supplement 25Labeling | Approved | None posted |
| Oct 11, 1973 | Supplement 26Labeling | Approved | None posted |
| May 9, 1973 | Supplement 24Manufacturing | Approved | None posted |
| Jan 19, 1973 | Supplement 23Labeling | Approved | None posted |
| Oct 5, 1972 | Supplement 22Manufacturing | Approved | None posted |
| Sep 25, 1972 | Supplement 21Labeling | Approved | None posted |
| Aug 31, 1972 | Supplement 20Manufacturing | Approved | None posted |
| Jun 16, 1972 | Supplement 19Manufacturing | Approved | None posted |
| Jan 26, 1972 | Supplement 17Labeling | Approved | None posted |
| Dec 6, 1971 | Supplement 16Manufacturing | Approved | None posted |
| Aug 9, 1971 | Supplement 15Labeling | Approved | None posted |
| May 21, 1971 | Original application | Approved |
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
