NDA 16366, held by Otsuka Icu Medcl. Sodium Chloride.
As of Nov 13, 2026, NDA 16366 (Sodium Chloride 0.9% In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Feb 24, 1972, with 142 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 |
|---|---|---|---|
| Feb 24, 1972 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sodium Chloride 0.9% In Plastic Container900MG/100ML · injectable;injection | Sodium Chloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 21, 2017 | Supplement 214Labeling · Standard review | Approved | |
| Apr 27, 2016 | Supplement 215Manufacturing · Standard review | Approved | None posted |
| Sep 17, 2014 | Supplement 201Manufacturing · Standard review | Approved | None posted |
| Sep 8, 2014 | Supplement 212Manufacturing · Standard review | Approved | None posted |
| Apr 16, 2007 | Supplement 174Labeling | Approved | None posted |
| Apr 10, 2006 | Supplement 167Labeling | Approved | None posted |
| Nov 1, 2002 | Supplement 161Manufacturing · Standard review | Approved | None posted |
| May 3, 2000 | Supplement 159Manufacturing · Standard review | Approved | None posted |
| May 3, 2000 | Supplement 160Labeling | Approved | None posted |
| Jun 25, 1999 | Supplement 153Labeling | Approved | None posted |
| Dec 1, 1998 | Supplement 157Manufacturing · Standard review | Approved | None posted |
| Aug 21, 1997 | Supplement 156Manufacturing · Standard review | Approved | None posted |
| Aug 20, 1997 | Supplement 155Manufacturing · Standard review | Approved | None posted |
| Jun 11, 1997 | Supplement 154Manufacturing · Standard review | Approved | None posted |
| Mar 28, 1997 | Supplement 152Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1996 | Supplement 151Manufacturing · Standard review | Approved | None posted |
| Mar 29, 1996 | Supplement 148Manufacturing · Standard review | Approved | None posted |
| Mar 29, 1996 | Supplement 149Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1996 | Supplement 150Manufacturing · Standard review | Approved | None posted |
| Aug 14, 1995 | Supplement 146Manufacturing · Standard review | Approved | None posted |
| May 24, 1994 | Supplement 145Labeling | Approved | None posted |
| Jan 28, 1992 | Supplement 141Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1991 | Supplement 140Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1991 | Supplement 142Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1990 | Supplement 137Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1990 | Supplement 138Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1989 | Supplement 136Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1988 | Supplement 135Manufacturing · Standard review | Approved | None posted |
| Jun 7, 1988 | Supplement 134Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1987 | Supplement 131Manufacturing · Standard review | Approved | None posted |
| Nov 26, 1986 | Supplement 130Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1986 | Supplement 96Manufacturing · Standard review | Approved | None posted |
| Jun 24, 1986 | Supplement 129Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1986 | Supplement 97Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1986 | Supplement 127Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 120Manufacturing · Standard review | Approved | None posted |
| Jan 18, 1986 | Supplement 128Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1985 | Supplement 100Labeling | Approved | None posted |
| Nov 29, 1985 | Supplement 99Manufacturing · Standard review | Approved | None posted |
| Nov 7, 1985 | Supplement 122Labeling | Approved | None posted |
| Oct 29, 1985 | Supplement 98Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 114Labeling | Approved | None posted |
| Oct 26, 1985 | Supplement 110Manufacturing · Standard review | Approved | None posted |
| Sep 26, 1985 | Supplement 104Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1985 | Supplement 119Manufacturing · Standard review | Approved | None posted |
| Jun 21, 1985 | Supplement 124Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1985 | Supplement 123Manufacturing · Standard review | Approved | None posted |
| May 3, 1985 | Supplement 111Manufacturing · Standard review | Approved | None posted |
| Apr 23, 1985 | Supplement 102Labeling | Approved | None posted |
| Apr 23, 1985 | Supplement 101Manufacturing · Standard review | Approved | None posted |
| Jan 18, 1985 | Supplement 109Labeling | Approved | None posted |
| Jan 18, 1985 | Supplement 108Manufacturing · Standard review | Approved | None posted |
| Jan 8, 1985 | Supplement 95Labeling | Approved | None posted |
| Jan 8, 1985 | Supplement 94Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1984 | Supplement 105Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1984 | Supplement 90Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1984 | Supplement 82Labeling | Approved | None posted |
| Oct 10, 1984 | Supplement 81Manufacturing · Standard review | Approved | None posted |
| Sep 25, 1984 | Supplement 91Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1984 | Supplement 92Manufacturing · Standard review | Approved | None posted |
| Apr 9, 1984 | Supplement 93Manufacturing · Standard review | Approved | None posted |
| Mar 21, 1984 | Supplement 89Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 79Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1983 | Supplement 86Manufacturing · Standard review | Approved | None posted |
| Sep 19, 1983 | Supplement 85Manufacturing · Standard review | Approved | None posted |
| Aug 31, 1983 | Supplement 88Manufacturing · Standard review | Approved | None posted |
| Jun 6, 1983 | Supplement 84Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1983 | Supplement 78Manufacturing · Standard review | Approved | None posted |
| Jan 25, 1983 | Supplement 83Manufacturing · Standard review | Approved | None posted |
| Jan 17, 1983 | Supplement 87Manufacturing · Standard review | Approved | None posted |
| Aug 31, 1982 | Supplement 65Labeling | Approved | None posted |
| Jul 26, 1982 | Supplement 80Manufacturing · Standard review | Approved | None posted |
| Jun 9, 1982 | Supplement 73Manufacturing · Standard review | Approved | None posted |
| May 26, 1982 | Supplement 77Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1982 | Supplement 76Labeling | Approved | None posted |
| Feb 1, 1982 | Supplement 75Manufacturing · Standard review | Approved | None posted |
| Jan 8, 1982 | Supplement 74Manufacturing · Standard review | Approved | None posted |
| Oct 21, 1981 | Supplement 71Labeling | Approved | None posted |
| Oct 21, 1981 | Supplement 70Manufacturing · Standard review | Approved | None posted |
| Sep 16, 1981 | Supplement 69Manufacturing · Standard review | Approved | None posted |
| Aug 25, 1981 | Supplement 72Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1981 | Supplement 68Labeling | Approved | None posted |
| Jul 31, 1981 | Supplement 67Manufacturing · Standard review | Approved | None posted |
| Jul 16, 1981 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 66Labeling | Approved | None posted |
| Mar 2, 1981 | Supplement 64Labeling | Approved | None posted |
| Mar 2, 1981 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Jan 7, 1981 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1980 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1980 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| May 28, 1980 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1980 | Supplement 51Labeling | Approved | None posted |
| Apr 16, 1980 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Apr 8, 1980 | Supplement 55Labeling | Approved | None posted |
| Feb 12, 1980 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Jan 21, 1980 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1979 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1979 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1979 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Nov 27, 1979 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1979 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Jul 17, 1979 | Supplement 46Labeling | Approved | None posted |
| Mar 27, 1979 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Mar 27, 1979 | Supplement 34Labeling | Approved | None posted |
| Mar 27, 1979 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Mar 27, 1979 | Supplement 40Labeling | Approved | None posted |
| Feb 16, 1979 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Feb 6, 1979 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1979 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Jan 5, 1979 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Nov 20, 1978 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Nov 3, 1978 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Oct 27, 1978 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Oct 27, 1978 | Supplement 37Labeling | Approved | None posted |
| Oct 25, 1978 | Supplement 42Labeling | Approved | None posted |
| Oct 25, 1978 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Sep 8, 1978 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Sep 8, 1978 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Aug 15, 1978 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Jun 26, 1978 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Jun 8, 1978 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jun 2, 1978 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Jun 2, 1978 | Supplement 24Labeling | Approved | None posted |
| May 31, 1978 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Apr 6, 1978 | Supplement 26Labeling | Approved | None posted |
| Apr 5, 1978 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Mar 15, 1978 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Feb 13, 1978 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Feb 8, 1978 | Supplement 25Labeling | Approved | None posted |
| Jan 23, 1978 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Sep 28, 1977 | Supplement 17Labeling | Approved | None posted |
| Aug 15, 1977 | Supplement 13Labeling | Approved | None posted |
| Aug 15, 1977 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1977 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Nov 8, 1976 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1976 | Supplement 1Labeling | Approved | None posted |
| Nov 20, 1975 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1975 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Sep 3, 1975 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| May 19, 1975 | Supplement 2Labeling | Approved | None posted |
| May 19, 1975 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Mar 7, 1975 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Feb 24, 1972 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
