NDA 18090, held by Otsuka Icu Medcl. Sodium Chloride.
As of Nov 13, 2026, NDA 18090 (Sodium Chloride 0.45% In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Apr 4, 1979, with 75 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 4, 1979 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sodium Chloride 0.45% In Plastic Container450MG/100ML · injectable;injection | Sodium Chloride | RxReference drug |
| Sep 21, 2017 | Supplement 116Labeling · Standard review | Approved | |
| Apr 16, 2017 | Supplement 86Labeling · Standard review | Approved | None posted |
| Sep 17, 2014 | Supplement 105Manufacturing · Standard review | Approved | None posted |
| Sep 8, 2014 | Supplement 114Manufacturing · Standard review | Approved | None posted |
| Apr 16, 2007 | Supplement 87Labeling | Approved | None posted |
| Nov 1, 2002 | Supplement 81Manufacturing · Standard review | Approved | None posted |
| Jun 25, 2001 | Supplement 80Manufacturing · Standard review | Approved | None posted |
| Jul 2, 1999 | Supplement 75Labeling | Approved | |
| Dec 1, 1998 | Supplement 78Manufacturing · Standard review | Approved | None posted |
| Sep 21, 1998 | Supplement 77Manufacturing · Standard review | Approved | None posted |
| Jun 11, 1997 | Supplement 76Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1996 | Supplement 72Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 71Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1996 | Supplement 74Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1996 | Supplement 73Manufacturing · Standard review | Approved | None posted |
| Aug 14, 1995 | Supplement 70Manufacturing · Standard review | Approved | None posted |
| May 19, 1994 | Supplement 69Manufacturing · Standard review | Approved | None posted |
| Oct 25, 1993 | Supplement 62Labeling | Approved | None posted |
| Oct 25, 1993 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1992 | Supplement 65Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1991 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1991 | Supplement 66Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1990 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1990 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Feb 6, 1989 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Feb 16, 1988 | Supplement 58Labeling | Approved | None posted |
| Feb 16, 1988 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1987 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Nov 26, 1986 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1986 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1986 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1985 | Supplement 39Labeling | Approved | None posted |
| Nov 29, 1985 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1985 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 47Labeling | Approved | None posted |
| Oct 26, 1985 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Sep 26, 1985 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1985 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| May 3, 1985 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1984 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1984 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1984 | Supplement 29Labeling | Approved | None posted |
| Oct 10, 1984 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Apr 9, 1984 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Mar 21, 1984 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1983 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Oct 25, 1983 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1983 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Aug 31, 1982 | Supplement 18Labeling | Approved | None posted |
| Jul 26, 1982 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Jul 8, 1982 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Jun 9, 1982 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1982 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Jan 8, 1982 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Oct 7, 1981 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 19Labeling | Approved | None posted |
| Mar 2, 1981 | Supplement 17Labeling | Approved | None posted |
| Mar 2, 1981 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jan 7, 1981 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1980 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jun 24, 1980 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1980 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| May 28, 1980 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| May 5, 1980 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Apr 8, 1980 | Supplement 9Labeling | Approved | None posted |
| Jan 22, 1980 | Supplement 4Labeling | Approved | None posted |
| Nov 29, 1979 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Nov 19, 1979 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Nov 9, 1979 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Nov 7, 1979 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Nov 7, 1979 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1979 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jul 6, 1979 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Apr 4, 1979 | 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
