NDA 16677, held by Baxter Hlthcare. Sodium Chloride.
As of Nov 14, 2026, NDA 16677 (Sodium Chloride 0.9% In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Dec 9, 1970, with 103 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 9, 1970 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Sodium Chloride 0.9% In Plastic Container900MG/100ML · solution;injection | Sodium Chloride | RxReference drug |
| Sodium Chloride 0.9% In Plastic Container450MG/50ML (9MG/ML) · solution;injection | Sodium Chloride | RxReference drug |
| Sodium Chloride 0.9% In Plastic Container225MG/25ML (9MG/ML) · solution;injection | Sodium Chloride | RxReference drug |
| Jul 24, 2024 | Supplement 185Labeling · Standard review | Approved | |
| May 29, 2019 | Supplement 169Labeling · Standard review | Approved | |
| Mar 9, 2018 | Supplement 160Manufacturing | Approved | |
| Mar 3, 2016 | Supplement 151Manufacturing · Standard review | Approved | |
| May 13, 2015 | Supplement 150Manufacturing · Standard review | Approved | |
| Dec 22, 2014 | Supplement 148Labeling · Standard review | Approved | |
| Jun 5, 2014 | Supplement 149Manufacturing · Standard review | Approved | None posted |
| Sep 11, 2013 | Supplement 147Labeling · Standard review | Approved | |
| Aug 26, 2005 | Supplement 139 | Approved | |
| May 23, 2005 | Supplement 137Labeling · Standard review | Approved | |
| Jul 17, 2003 | Supplement 131Manufacturing · Standard review | Approved | |
| Sep 16, 2002 | Supplement 128Manufacturing · Standard review | Approved | None posted |
| Apr 3, 2002 | Supplement 124Labeling · Standard review | Approved | |
| Aug 14, 2001 | Supplement 126Manufacturing · Standard review | Approved | None posted |
| Nov 24, 1999 | Supplement 125Manufacturing · Standard review | Approved | None posted |
| Dec 31, 1997 | Supplement 123Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1997 | Supplement 121Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1997 | Supplement 122Manufacturing · Standard review | Approved | None posted |
| Nov 14, 1996 | Supplement 119Manufacturing · Standard review | Approved | None posted |
| Oct 11, 1996 | Supplement 120Manufacturing · Standard review | Approved | None posted |
| Sep 27, 1995 | Supplement 118Manufacturing · Standard review | Approved | None posted |
| Sep 30, 1994 | Supplement 116Manufacturing · Standard review | Approved | None posted |
| Feb 18, 1994 | Supplement 117Manufacturing · Standard review | Approved | None posted |
| Jun 1, 1993 | Supplement 111Manufacturing · Standard review | Approved | None posted |
| Jan 6, 1993 | Supplement 115Manufacturing · Standard review | Approved | None posted |
| Nov 23, 1992 | Supplement 110Manufacturing · Standard review | Approved | None posted |
| Mar 26, 1991 | Supplement 109Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1991 | Supplement 106Manufacturing · Standard review | Approved | None posted |
| May 24, 1990 | Supplement 108Manufacturing · Standard review | Approved | None posted |
| Mar 23, 1990 | Supplement 107Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1989 | Supplement 105Manufacturing · Standard review | Approved | None posted |
| Jan 12, 1989 | Supplement 104Manufacturing · Standard review | Approved | None posted |
| Jan 10, 1989 | Supplement 102Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1988 | Supplement 103Manufacturing · Standard review | Approved | None posted |
| Jul 25, 1987 | Supplement 100Manufacturing · Standard review | Approved | None posted |
| May 28, 1987 | Supplement 99Manufacturing · Standard review | Approved | None posted |
| Apr 27, 1987 | Supplement 101Manufacturing · Standard review | Approved | None posted |
| Feb 27, 1986 | Supplement 96Manufacturing · Standard review | Approved | None posted |
| Oct 30, 1985 | Supplement 88Manufacturing · Standard review | Approved | None posted |
| Oct 30, 1985 | Supplement 89Labeling | Approved | None posted |
| Aug 28, 1985 | Supplement 82Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1985 | Supplement 83Manufacturing · Standard review | Approved | None posted |
| Jun 13, 1985 | Supplement 91Manufacturing · Standard review | Approved | None posted |
| Apr 15, 1985 | Supplement 94Labeling | Approved | None posted |
| Apr 15, 1985 | Supplement 95Manufacturing · Standard review | Approved | None posted |
| Jan 24, 1985 | Supplement 80Manufacturing · Standard review | Approved | None posted |
| Sep 22, 1984 | Supplement 90Manufacturing · Standard review | Approved | None posted |
| Sep 21, 1984 | Supplement 87Manufacturing · Standard review | Approved | None posted |
| Mar 16, 1984 | Supplement 81Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1984 | Supplement 86Manufacturing · Standard review | Approved | None posted |
| Jul 11, 1983 | Supplement 75Labeling | Approved | None posted |
| Jun 3, 1982 | Supplement 72Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1982 | Supplement 70Manufacturing · Standard review | Approved | None posted |
| Apr 8, 1982 | Supplement 77Labeling | Approved | None posted |
| Feb 16, 1982 | Supplement 76Manufacturing · Standard review | Approved | None posted |
| Dec 21, 1981 | Supplement 68Manufacturing · Standard review | Approved | None posted |
| Nov 20, 1981 | Supplement 74Manufacturing · Standard review | Approved | None posted |
| Nov 9, 1981 | Supplement 71Manufacturing · Standard review | Approved | None posted |
| Aug 26, 1981 | Supplement 69Labeling | Approved | None posted |
| Aug 6, 1981 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Jun 29, 1981 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| May 20, 1981 | Supplement 67Manufacturing · Standard review | Approved | None posted |
| Apr 23, 1981 | Supplement 65Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1981 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Jan 21, 1981 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Aug 7, 1980 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1980 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Jun 28, 1980 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Jun 18, 1980 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| May 30, 1980 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| May 30, 1980 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1980 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1980 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Aug 2, 1979 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Mar 23, 1979 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Nov 3, 1978 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Oct 20, 1978 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Sep 8, 1978 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Aug 7, 1978 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Aug 2, 1978 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Jun 20, 1978 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Apr 25, 1978 | Supplement 43Labeling | Approved | None posted |
| Mar 24, 1978 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Mar 22, 1978 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1978 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1978 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1978 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1978 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Dec 14, 1977 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Jun 6, 1977 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Feb 7, 1977 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Oct 20, 1976 | Supplement 22Labeling | Approved | None posted |
| Oct 18, 1976 | Supplement 32Labeling | Approved | None posted |
| Jul 13, 1976 | Supplement 31Labeling | Approved | None posted |
| Jul 1, 1976 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Jun 17, 1976 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| May 11, 1976 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Jan 5, 1976 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Jan 2, 1976 | Supplement 26Labeling | Approved | None posted |
| Sep 25, 1975 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Sep 23, 1975 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Sep 17, 1975 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Jul 10, 1975 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Dec 9, 1970 | 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
