NDA 17939, held by Glaxosmithkline. Cimetidine Hydrochloride.
As of Nov 13, 2026, NDA 17939 (Tagamet), held by Glaxosmithkline, was first approved by FDA on Aug 16, 1977, with 69 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 13, 1991 | Supplement 77Efficacy (new indication or use) · Priority review | Approved | None posted |
| Nov 13, 1989 | Supplement 66Efficacy (new indication or use) · Priority review | Approved | None posted |
| Mar 31, 1988 | Supplement 64Efficacy (new indication or use) · Priority review | Approved | None posted |
| Apr 29, 1986 | Supplement 55Efficacy (new indication or use) · Priority review | Approved | None posted |
| Nov 20, 1985 | Supplement 39Efficacy (new indication or use) · Priority review | Approved | None posted |
| Jan 31, 1983 | Supplement 41Efficacy (new indication or use) · Priority review | Approved | None posted |
| Dec 30, 1982 | Supplement 26Efficacy (new indication or use) · Priority review | Approved | None posted |
| Aug 25, 1982 | Supplement 38Efficacy (new indication or use) · Priority review | Approved | None posted |
| Mar 16, 1979 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | None posted |
| Aug 16, 1977 | Original applicationNew dosage form · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| TagametEQ 300MG BASE/2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cimetidine Hydrochloride | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 15, 1997 | Supplement 86Manufacturing · Priority review | Approved | None posted |
| Feb 22, 1995 | Supplement 85Labeling · Priority review | Approved | None posted |
| Nov 10, 1993 | Supplement 84Manufacturing · Priority review | Approved | None posted |
| Jun 8, 1993 | Supplement 83Manufacturing · Priority review | Approved | None posted |
| Aug 27, 1992 | Supplement 79Manufacturing · Priority review | Approved | None posted |
| Jul 16, 1992 | Supplement 81Manufacturing · Priority review | Approved | None posted |
| Jan 7, 1992 | Supplement 80Labeling · Priority review | Approved | None posted |
| Nov 13, 1991 | Supplement 77Efficacy (new indication or use) · Priority review | Approved | None posted |
| Mar 7, 1991 | Supplement 73Labeling · Priority review | Approved | None posted |
| May 30, 1990 | Supplement 74Manufacturing · Priority review | Approved | None posted |
| Mar 21, 1990 | Supplement 76Manufacturing · Priority review | Approved | None posted |
| Nov 13, 1989 | Supplement 66Efficacy (new indication or use) · Priority review | Approved | None posted |
| Jun 26, 1989 | Supplement 72Labeling · Priority review | Approved | None posted |
| Jun 26, 1989 | Supplement 70Labeling · Priority review | Approved | None posted |
| Mar 20, 1989 | Supplement 71Manufacturing · Priority review | Approved | None posted |
| Jun 15, 1988 | Supplement 68Labeling · Priority review | Approved | None posted |
| May 20, 1988 | Supplement 67Labeling · Priority review | Approved | None posted |
| Mar 31, 1988 | Supplement 64Efficacy (new indication or use) · Priority review | Approved | None posted |
| Jun 3, 1987 | Supplement 65Manufacturing · Priority review | Approved | None posted |
| Jul 24, 1986 | Supplement 63Manufacturing · Priority review | Approved | None posted |
| Apr 29, 1986 | Supplement 55Efficacy (new indication or use) · Priority review | Approved | None posted |
| Apr 23, 1986 | Supplement 61Labeling · Priority review | Approved | None posted |
| Jan 13, 1986 | Supplement 59Labeling · Priority review | Approved | None posted |
| Nov 20, 1985 | Supplement 39Efficacy (new indication or use) · Priority review | Approved | None posted |
| May 15, 1985 | Supplement 58Labeling · Priority review | Approved | None posted |
| Apr 18, 1985 | Supplement 57Labeling · Priority review | Approved | None posted |
| Feb 7, 1985 | Supplement 56Labeling · Priority review | Approved | None posted |
| Jan 23, 1985 | Supplement 54Manufacturing · Priority review | Approved | None posted |
| Jul 19, 1984 | Supplement 52Labeling · Priority review | Approved | None posted |
| Jul 19, 1984 | Supplement 45Labeling · Priority review | Approved | None posted |
| Jul 11, 1984 | Supplement 51Manufacturing · Priority review | Approved | None posted |
| Jun 18, 1984 | Supplement 53Labeling · Priority review | Approved | None posted |
| Mar 5, 1984 | Supplement 50Labeling · Priority review | Approved | None posted |
| Mar 5, 1984 | Supplement 49Labeling · Priority review | Approved | None posted |
| Feb 28, 1984 | Supplement 44Manufacturing · Priority review | Approved | None posted |
| Nov 29, 1983 | Supplement 47Labeling · Priority review | Approved | None posted |
| Apr 22, 1983 | Supplement 40Manufacturing · Priority review | Approved | None posted |
| Feb 28, 1983 | Supplement 42Labeling · Priority review | Approved | None posted |
| Jan 31, 1983 | Supplement 41Efficacy (new indication or use) · Priority review | Approved | None posted |
| Dec 30, 1982 | Supplement 32Labeling · Priority review | Approved | None posted |
| Dec 30, 1982 | Supplement 26Efficacy (new indication or use) · Priority review | Approved | None posted |
| Aug 25, 1982 | Supplement 38Efficacy (new indication or use) · Priority review | Approved | None posted |
| Feb 4, 1982 | Supplement 36Labeling · Priority review | Approved | None posted |
| Jan 22, 1982 | Supplement 34Labeling · Priority review | Approved | None posted |
| Dec 3, 1981 | Supplement 33Manufacturing · Priority review | Approved | None posted |
| Nov 2, 1981 | Supplement 31Labeling · Priority review | Approved | None posted |
| Aug 28, 1981 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Jul 13, 1981 | Supplement 30Labeling · Priority review | Approved | None posted |
| Jan 22, 1981 | Supplement 28Labeling · Priority review | Approved | None posted |
| Jan 22, 1981 | Supplement 27Labeling · Priority review | Approved | None posted |
| Jul 8, 1980 | Supplement 25Labeling · Priority review | Approved | None posted |
| Jul 8, 1980 | Supplement 24Labeling · Priority review | Approved | None posted |
| Jul 8, 1980 | Supplement 23Labeling · Priority review | Approved | None posted |
| Feb 11, 1980 | Supplement 21Labeling · Priority review | Approved | None posted |
| Jan 17, 1980 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Jan 8, 1980 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Apr 5, 1979 | Supplement 17Labeling · Priority review | Approved | None posted |
| Mar 16, 1979 | Supplement 16Labeling · Priority review | Approved | None posted |
| Mar 16, 1979 | Supplement 5Labeling · Priority review | Approved | None posted |
| Mar 16, 1979 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | None posted |
| Feb 1, 1979 | Supplement 15Labeling · Priority review | Approved | None posted |
| Dec 4, 1978 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Dec 4, 1978 | Supplement 10Labeling · Priority review | Approved | None posted |
| Nov 30, 1978 | Supplement 13Labeling · Priority review | Approved | None posted |
| Nov 30, 1978 | Supplement 12Labeling · Priority review | Approved | None posted |
| Sep 28, 1978 | Supplement 9Labeling · Priority review | Approved | None posted |
| Sep 28, 1978 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Dec 27, 1977 | Supplement 3Labeling · Priority review | Approved | None posted |
| Dec 27, 1977 | Supplement 1Labeling · Priority review | Approved | None posted |
| Aug 16, 1977 | Original applicationNew dosage form · 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
