NDA 16403, held by Ge Healthcare. Diatrizoate Meglumine.
As of Nov 13, 2026, NDA 16403 (Hypaque, Hypaque-Cysto), held by Ge Healthcare, was first approved by FDA on Aug 21, 1969, with 59 approved supplements and 0 published complete response letters.
| Jan 24, 1984 | Supplement 37Efficacy (new indication or use) · Priority review | Approved | None posted |
| Jul 28, 1978 | Supplement 23Efficacy (new indication or use) · Priority review | Approved | None posted |
| Aug 21, 1969 | Original applicationNew dosage form · Priority review | Approved | None posted |
| Hypaque60% · injectable;injection | Diatrizoate Meglumine | Discontinued |
| Hypaque30% · injectable;injection | Diatrizoate Meglumine | Discontinued |
| Hypaque-Cysto30% · solution;urethral | Diatrizoate Meglumine | Discontinued |
| Sep 30, 2002 | Supplement 71Labeling · Priority review | Approved | |
| Aug 13, 2001 | Supplement 70Manufacturing · Priority review | Approved | None posted |
| Aug 20, 1998 | Supplement 69Manufacturing · Priority review | Approved | None posted |
| Jun 15, 1995 | Supplement 68Labeling · Priority review | Approved | None posted |
| Mar 25, 1994 | Supplement 67Manufacturing · Priority review | Approved | None posted |
| Oct 3, 1991 | Supplement 64Labeling · Priority review | Approved | None posted |
| Oct 3, 1991 | Supplement 65Labeling · Priority review | Approved | None posted |
| Oct 3, 1991 | Supplement 66Labeling · Priority review | Approved | None posted |
| Apr 24, 1991 | Supplement 63Manufacturing · Priority review | Approved | None posted |
| Feb 26, 1990 | Supplement 53Manufacturing · Priority review | Approved | None posted |
| Oct 26, 1989 | Supplement 62Manufacturing · Priority review | Approved | None posted |
| Jun 28, 1989 | Supplement 61Labeling · Priority review | Approved | None posted |
| Jun 22, 1989 | Supplement 56Manufacturing · Priority review | Approved | None posted |
| Jun 22, 1989 | Supplement 57Manufacturing · Priority review | Approved | None posted |
| May 26, 1989 | Supplement 60Labeling · Priority review | Approved | None posted |
| May 19, 1989 | Supplement 59Labeling · Priority review | Approved | None posted |
| Apr 18, 1989 | Supplement 58Manufacturing · Priority review | Approved | None posted |
| Apr 11, 1989 | Supplement 55Manufacturing · Priority review | Approved | None posted |
| May 23, 1988 | Supplement 46Manufacturing · Priority review | Approved | None posted |
| Feb 22, 1988 | Supplement 54Labeling · Priority review | Approved | None posted |
| Feb 10, 1986 | Supplement 52Labeling · Priority review | Approved | None posted |
| Nov 22, 1985 | Supplement 51Labeling · Priority review | Approved | None posted |
| Sep 11, 1985 | Supplement 41Manufacturing · Priority review | Approved | None posted |
| Apr 23, 1985 | Supplement 49Labeling · Priority review | Approved | None posted |
| Apr 19, 1985 | Supplement 48Labeling · Priority review | Approved | None posted |
| Apr 16, 1985 | Supplement 50Labeling · Priority review | Approved | None posted |
| Jan 14, 1985 | Supplement 44Manufacturing · Priority review | Approved | None posted |
| Nov 26, 1984 | Supplement 47Labeling · Priority review | Approved | None posted |
| Mar 12, 1984 | Supplement 42Labeling · Priority review | Approved | None posted |
| Mar 12, 1984 | Supplement 38Labeling · Priority review | Approved | None posted |
| Jan 24, 1984 | Supplement 37Efficacy (new indication or use) · Priority review | Approved | None posted |
| Jan 16, 1984 | Supplement 35Labeling · Priority review | Approved | None posted |
| Oct 4, 1983 | Supplement 33Manufacturing · Priority review | Approved | None posted |
| Feb 28, 1983 | Supplement 40Manufacturing · Priority review | Approved | None posted |
| Jan 25, 1983 | Supplement 45Manufacturing · Priority review | Approved | None posted |
| Oct 18, 1982 | Supplement 43Manufacturing · Priority review | Approved | None posted |
| Mar 18, 1982 | Supplement 39Manufacturing · Priority review | Approved | None posted |
| Feb 24, 1982 | Supplement 36Manufacturing · Priority review | Approved | None posted |
| Jan 18, 1982 | Supplement 34Manufacturing · Priority review | Approved | None posted |
| Apr 27, 1981 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| Apr 11, 1981 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Apr 17, 1979 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| Feb 15, 1979 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Feb 15, 1979 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Feb 15, 1979 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Jul 28, 1978 | Supplement 23Efficacy (new indication or use) · Priority review | Approved | None posted |
| Jan 30, 1978 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Jan 30, 1978 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Jan 30, 1978 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Apr 1, 1977 | Supplement 22Labeling · Priority review | Approved | None posted |
| Jun 25, 1976 | Supplement 18Labeling · Priority review | Approved | None posted |
| Jun 21, 1976 | Supplement 17Labeling · Priority review | Approved | None posted |
| Jun 2, 1976 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Jun 2, 1976 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Jun 2, 1976 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Aug 22, 1975 | Supplement 12Labeling · Priority review | Approved | None posted |
| May 29, 1975 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| May 29, 1975 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| May 29, 1975 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Aug 21, 1969 | 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
