NDA 17493, held by Baxter Hlthcare. Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride, Amino Acids.
As of Nov 13, 2026, NDA 17493 (Travasol 5.5% W/ Electrolytes, Travasol 8.5% W/ Electrolytes, Travasol 3.5% W/ Electrolytes), held by Baxter Hlthcare, was first approved by FDA on Mar 24, 1976, with 59 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 24, 1976 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Travasol 5.5% W/ Electrolytes5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML · injectable;injection | Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride | Discontinued |
| Travasol 8.5% W/ Electrolytes8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/100ML · injectable;injection | Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride | Discontinued |
| Travasol 3.5% W/ Electrolytes3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML · injectable;injection | Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride | Discontinued |
| Travasol 5.5% W/O Electrolytes5.5% (5.5GM/100ML) · injectable;injection | Amino Acids | Discontinued |
| Travasol 8.5% W/O Electrolytes8.5% (8.5GM/100ML) · injectable;injection | Amino Acids | Discontinued |
| Travasol 10% W/O Electrolytes10% (10GM/100ML) · injectable;injection | Amino Acids | Discontinued |
| Renamin W/O Electrolytes6.5% (6.5GM/100ML) · injectable;injection | Amino Acids | Discontinued |
| Apr 30, 2003 | Supplement 66Labeling · Standard review | Approved | |
| Jan 17, 2003 | Supplement 67Manufacturing · Standard review | Approved | |
| Jan 3, 2003 | Supplement 65Labeling · Standard review | Approved | |
| Apr 5, 1999 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Mar 31, 1999 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Apr 30, 1997 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Sep 30, 1994 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| May 19, 1994 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Feb 18, 1994 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Mar 12, 1993 | Supplement 56Labeling · Standard review | Approved | None posted |
| Mar 12, 1993 | Supplement 53Labeling · Standard review | Approved | None posted |
| Sep 14, 1992 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Aug 24, 1992 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Apr 3, 1991 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Mar 26, 1991 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| May 4, 1990 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1989 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Dec 30, 1987 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Nov 18, 1987 | Supplement 48Labeling · Standard review | Approved | None posted |
| Jul 25, 1987 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Sep 20, 1985 | Supplement 46Labeling · Standard review | Approved | None posted |
| Jan 24, 1985 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1984 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Jan 19, 1983 | Supplement 43Labeling · Standard review | Approved | None posted |
| Jan 19, 1983 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Oct 15, 1982 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Oct 15, 1982 | Supplement 33Labeling · Standard review | Approved | None posted |
| Jul 21, 1982 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Apr 6, 1982 | Supplement 37Labeling · Standard review | Approved | None posted |
| Apr 6, 1982 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Mar 8, 1982 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Feb 16, 1982 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Dec 16, 1981 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Jun 29, 1981 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Jun 17, 1981 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Jun 17, 1981 | Supplement 29Labeling · Standard review | Approved | None posted |
| Jul 31, 1980 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Jun 3, 1980 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Nov 28, 1979 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Nov 28, 1979 | Supplement 20Labeling · Standard review | Approved | None posted |
| Jun 4, 1979 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| May 10, 1979 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Apr 27, 1979 | Supplement 21Labeling · Standard review | Approved | None posted |
| Aug 29, 1978 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jul 28, 1978 | Supplement 17Labeling · Standard review | Approved | None posted |
| Jul 28, 1978 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Dec 13, 1977 | Supplement 15Labeling · Standard review | Approved | None posted |
| Dec 7, 1977 | Supplement 6Labeling · Standard review | Approved | None posted |
| Aug 18, 1977 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jul 22, 1977 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jul 12, 1977 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jul 12, 1977 | Supplement 13Labeling · Standard review | Approved | None posted |
| Apr 1, 1977 | Supplement 7Labeling · Standard review | Approved | None posted |
| Apr 1, 1977 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Feb 7, 1977 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Sep 8, 1976 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 24, 1976 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jul 19, 1976 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jun 28, 1976 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Mar 24, 1976 | Original applicationNew formulation or manufacturer · Standard 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
