NDA 18379, held by Fresenius Medcl. Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate.
As of Nov 13, 2026, NDA 18379 (Delflex W/ Dextrose 4.25% In Plastic Container, Delflex W/ Dextrose 1.5% In Plastic Container, Delflex W/ Dextrose 2.5% In Plastic Container), held by Fresenius Medcl, was first approved by FDA on Sep 3, 1980, with 87 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 3, 1980 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Delflex W/ Dextrose 4.25% In Plastic Container25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML · solution;intraperitoneal | Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate | Discontinued |
| Delflex W/ Dextrose 1.5% In Plastic Container25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML · solution;intraperitoneal | Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate | Discontinued |
| Delflex W/ Dextrose 2.5% In Plastic Container25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML · solution;intraperitoneal | Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate | Discontinued |
| Delflex-Lm W/ Dextrose 1.5% In Plastic Container25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML · solution;intraperitoneal | Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate | Discontinued |
| Delflex-Lm W/ Dextrose 2.5% In Plastic Container25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML · solution;intraperitoneal | Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate | Discontinued |
| Delflex-Lm W/ Dextrose 4.25% In Plastic Container25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML · solution;intraperitoneal | Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate | Discontinued |
| Delflex W/ Dextrose 3.5% In Plastic Container25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML · solution;intraperitoneal | Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate | Discontinued |
| Delflex-Lm W/ Dextrose 3.5% In Plastic Container25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML · solution;intraperitoneal | Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate | Discontinued |
| Nov 9, 2001 | Supplement 95Manufacturing · Standard review | Approved | None posted |
| Sep 27, 1999 | Supplement 96Manufacturing · Standard review | Approved | None posted |
| Aug 14, 1997 | Supplement 94Manufacturing · Standard review | Approved | None posted |
| Nov 1, 1996 | Supplement 92Manufacturing · Standard review | Approved | None posted |
| Jul 3, 1996 | Supplement 93Manufacturing · Standard review | Approved | None posted |
| Feb 7, 1996 | Supplement 91Manufacturing · Standard review | Approved | None posted |
| Jan 23, 1996 | Supplement 89Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1992 | Supplement 84Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1991 | Supplement 83Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1991 | Supplement 85Manufacturing · Standard review | Approved | None posted |
| Aug 1, 1990 | Supplement 80Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1990 | Supplement 79Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1990 | Supplement 81Manufacturing · Standard review | Approved | None posted |
| Jun 22, 1989 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1989 | Supplement 78Manufacturing · Standard review | Approved | None posted |
| Jun 24, 1988 | Supplement 71Manufacturing · Standard review | Approved | None posted |
| Jun 24, 1988 | Supplement 72Labeling | Approved | None posted |
| Jun 24, 1988 | Supplement 73Manufacturing · Standard review | Approved | None posted |
| Jun 24, 1988 | Supplement 74Labeling | Approved | None posted |
| Feb 24, 1988 | Supplement 77Manufacturing · Standard review | Approved | None posted |
| Feb 2, 1988 | Supplement 76Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1987 | Supplement 69Manufacturing · Standard review | Approved | None posted |
| Apr 28, 1987 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Apr 28, 1987 | Supplement 64Labeling | Approved | None posted |
| Feb 27, 1987 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Feb 27, 1987 | Supplement 62Labeling | Approved | None posted |
| Feb 11, 1987 | Supplement 65Manufacturing · Standard review | Approved | None posted |
| Feb 11, 1987 | Supplement 66Manufacturing · Standard review | Approved | None posted |
| Nov 26, 1986 | Supplement 68Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1986 | Supplement 67Manufacturing · Standard review | Approved | None posted |
| Feb 26, 1986 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Feb 26, 1986 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Feb 21, 1986 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Jan 18, 1986 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Jan 18, 1986 | Supplement 54Labeling | Approved | None posted |
| Jan 18, 1986 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Jan 18, 1986 | Supplement 56Labeling | Approved | None posted |
| Dec 10, 1985 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Dec 10, 1985 | Supplement 42Labeling | Approved | None posted |
| Dec 6, 1985 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1985 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Oct 24, 1985 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Oct 24, 1985 | Supplement 49Labeling | Approved | None posted |
| Oct 2, 1985 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Oct 2, 1985 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Oct 2, 1985 | Supplement 51Labeling | Approved | None posted |
| Oct 2, 1985 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Oct 2, 1985 | Supplement 44Labeling | Approved | None posted |
| Oct 2, 1985 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Sep 26, 1985 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Sep 6, 1985 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| May 1, 1985 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Mar 15, 1985 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Nov 28, 1984 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1984 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1984 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1984 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1984 | Supplement 22Labeling | Approved | None posted |
| Sep 8, 1984 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Jun 8, 1984 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Mar 21, 1984 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Feb 17, 1984 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Jan 25, 1984 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Jan 25, 1984 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Jul 5, 1983 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Aug 5, 1982 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Aug 5, 1982 | Supplement 14Labeling | Approved | None posted |
| Jul 26, 1982 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Jul 21, 1982 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Jul 7, 1982 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jul 7, 1982 | Supplement 16Labeling | Approved | None posted |
| Jul 4, 1982 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Jul 4, 1982 | Supplement 19Labeling | Approved | None posted |
| Jun 9, 1982 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jun 9, 1982 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Apr 9, 1982 | Supplement 3Labeling | Approved | None posted |
| Mar 11, 1982 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Mar 11, 1982 | Supplement 10Labeling | Approved | None posted |
| Feb 1, 1982 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jan 8, 1982 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Oct 1, 1981 | Supplement 7Labeling | Approved | None posted |
| Sep 16, 1981 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Apr 23, 1981 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jan 19, 1981 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Oct 31, 1980 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Sep 3, 1980 | 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
