NDA 50006, held by Pfizer. Doxycycline.
As of Nov 14, 2026, NDA 50006 (Vibramycin), held by Pfizer, was first approved by FDA on Dec 6, 1967, with 86 approved supplements and 0 published complete response letters.
| Dec 15, 1992 | Supplement 73Efficacy (new indication or use) | Approved | None posted |
| Dec 6, 1967 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| VibramycinEQ 25MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · for suspension;oral | Doxycycline | DiscontinuedReference drug |
| Aug 8, 2025 | Supplement 96Labeling · Standard review | Approved | |
| Mar 31, 2025 | Supplement 95Labeling · Standard review | Approved | |
| Dec 20, 2019 | Supplement 92Labeling · Standard review | Approved | |
| Dec 3, 2018 | Supplement 91Labeling · Standard review | Approved | |
| Jul 26, 2017 | Supplement 89Labeling · Standard review | Approved | |
| Dec 21, 2016 | Supplement 88Labeling · Standard review | Approved | |
| Mar 31, 2016 | Supplement 87Labeling · Standard review | Approved | |
| Sep 12, 2014 | Supplement 86Labeling · Standard review | Approved | |
| Sep 4, 2013 | Supplement 85Labeling · Standard review | Approved | |
| Apr 29, 2013 | Supplement 84Labeling · Standard review | Approved | |
| May 11, 2011 | Supplement 82Labeling · Standard review | Approved | |
| Feb 6, 2008 | Supplement 79Labeling · Standard review | Approved | |
| Mar 12, 2004 | Supplement 76Labeling · Standard review | Approved | |
| Jun 18, 2002 | Supplement 74Labeling · Standard review | Approved | |
| Dec 15, 1992 | Supplement 73Efficacy (new indication or use) | Approved | None posted |
| May 11, 1992 | Supplement 5Labeling | Approved | None posted |
| May 11, 1992 | Supplement 7Labeling | Approved | None posted |
| Aug 23, 1991 | Supplement 4Labeling | Approved | None posted |
| Nov 21, 1983 | Supplement 2Labeling | Approved | None posted |
| Mar 29, 1983 | Supplement 1Labeling | Approved | None posted |
| Aug 31, 1982 | Supplement 72Labeling | Approved | None posted |
| Oct 20, 1981 | Supplement 70Manufacturing | Approved | None posted |
| Oct 19, 1981 | Supplement 71Manufacturing | Approved | None posted |
| Sep 17, 1980 | Supplement 69Manufacturing | Approved | None posted |
| Sep 16, 1980 | Supplement 68Manufacturing | Approved | None posted |
| Aug 12, 1980 | Supplement 67Labeling | Approved | None posted |
| Sep 20, 1979 | Supplement 65Manufacturing | Approved | None posted |
| Sep 19, 1979 | Supplement 66Manufacturing | Approved | None posted |
| Oct 19, 1978 | Supplement 64Manufacturing | Approved | None posted |
| Jul 12, 1978 | Supplement 62Labeling | Approved | None posted |
| Jul 12, 1978 | Supplement 63Labeling | Approved | None posted |
| Mar 13, 1978 | Supplement 61Labeling | Approved | None posted |
| Sep 21, 1977 | Supplement 59Manufacturing | Approved | None posted |
| Sep 20, 1977 | Supplement 60Labeling | Approved | None posted |
| Sep 14, 1977 | Supplement 58Manufacturing | Approved | None posted |
| Dec 6, 1976 | Supplement 57Manufacturing | Approved | None posted |
| Sep 13, 1976 | Supplement 56Manufacturing | Approved | None posted |
| Sep 10, 1976 | Supplement 55Manufacturing | Approved | None posted |
| May 20, 1976 | Supplement 54Manufacturing | Approved | None posted |
| Apr 9, 1976 | Supplement 53Manufacturing | Approved | None posted |
| Jan 15, 1976 | Supplement 52Labeling | Approved | None posted |
| Dec 1, 1975 | Supplement 51Manufacturing | Approved | None posted |
| Sep 16, 1975 | Supplement 48Manufacturing | Approved | None posted |
| Sep 3, 1975 | Supplement 49Manufacturing | Approved | None posted |
| Sep 3, 1975 | Supplement 50Manufacturing | Approved | None posted |
| Apr 18, 1975 | Supplement 47Labeling | Approved | None posted |
| Sep 24, 1974 | Supplement 45Manufacturing | Approved | None posted |
| Sep 24, 1974 | Supplement 46Manufacturing | Approved | None posted |
| Jun 21, 1974 | Supplement 44Manufacturing | Approved | None posted |
| Jun 6, 1974 | Supplement 43Labeling | Approved | None posted |
| Apr 16, 1974 | Supplement 42Labeling | Approved | None posted |
| Oct 30, 1973 | Supplement 36Labeling | Approved | None posted |
| Oct 30, 1973 | Supplement 37Labeling | Approved | None posted |
| Oct 30, 1973 | Supplement 38Labeling | Approved | None posted |
| Oct 30, 1973 | Supplement 39Labeling | Approved | None posted |
| Oct 2, 1973 | Supplement 40Manufacturing | Approved | None posted |
| Oct 2, 1973 | Supplement 41Manufacturing | Approved | None posted |
| Jul 2, 1973 | Supplement 35Labeling | Approved | None posted |
| Mar 16, 1973 | Supplement 34Labeling | Approved | None posted |
| Sep 18, 1972 | Supplement 33Manufacturing | Approved | None posted |
| Jun 23, 1972 | Supplement 32Labeling | Approved | None posted |
| Jun 9, 1972 | Supplement 31Labeling | Approved | None posted |
| Sep 16, 1971 | Supplement 30Manufacturing | Approved | None posted |
| May 25, 1971 | Supplement 29Labeling | Approved | None posted |
| Mar 12, 1971 | Supplement 28Labeling | Approved | None posted |
| Feb 22, 1971 | Supplement 27Manufacturing | Approved | None posted |
| Feb 8, 1971 | Supplement 26Labeling | Approved | None posted |
| Oct 14, 1970 | Supplement 24Manufacturing | Approved | None posted |
| Oct 9, 1970 | Supplement 25Manufacturing | Approved | None posted |
| Apr 1, 1970 | Supplement 23Manufacturing | Approved | None posted |
| Mar 12, 1970 | Supplement 21Manufacturing | Approved | None posted |
| Mar 12, 1970 | Supplement 22Manufacturing | Approved | None posted |
| Nov 19, 1969 | Supplement 20Labeling | Approved | None posted |
| Nov 7, 1969 | Supplement 19Manufacturing | Approved | None posted |
| Sep 9, 1969 | Supplement 17Manufacturing | Approved | None posted |
| Sep 8, 1969 | Supplement 18Manufacturing | Approved | None posted |
| Jul 31, 1969 | Supplement 16Labeling | Approved | None posted |
| Jun 12, 1969 | Supplement 15Manufacturing | Approved | None posted |
| Feb 11, 1969 | Supplement 13Labeling | Approved | None posted |
| Feb 11, 1969 | Supplement 14Manufacturing | Approved | None posted |
| Dec 30, 1968 | Supplement 12Labeling | Approved | None posted |
| Dec 18, 1968 | Supplement 11Manufacturing | Approved | None posted |
| Jun 19, 1968 | Supplement 9Manufacturing | Approved | None posted |
| Jun 13, 1968 | Supplement 10Labeling | Approved | None posted |
| Apr 8, 1968 | Supplement 8Manufacturing | Approved | None posted |
| Feb 5, 1968 | Supplement 6Manufacturing | Approved | None posted |
| Dec 6, 1967 | 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
