NDA 18314, held by Otsuka Icu Medcl. Sodium Chloride.
As of Nov 13, 2026, NDA 18314 (Sodium Chloride 0.9% In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Feb 22, 1980, with 46 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE This sterile, nonpyrogenic electrolyte solution is indicated for all general irrigation, washing, rinsing and dilution purposes including blood cell washing (when used in conjunction with automated intraoperative blood salvaging equipment).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 22, 1980 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sodium Chloride 0.9% In Plastic Container900MG/100ML · solution;irrigation | Sodium Chloride | Rx |
| Feb 7, 2011 | Supplement 62Labeling | Approved | None posted |
| Aug 6, 2004 | Supplement 53Labeling | Approved | None posted |
| Aug 21, 1997 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Jun 11, 1997 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Mar 28, 1997 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1996 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1996 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Aug 14, 1995 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1992 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1991 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1991 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1990 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1990 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1989 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Feb 6, 1989 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1987 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Nov 26, 1986 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1986 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1986 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1986 | Supplement 28Labeling | Approved | None posted |
| Feb 22, 1986 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1985 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Sep 26, 1985 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1984 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1984 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Sep 22, 1984 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Sep 22, 1984 | Supplement 15Labeling | Approved | None posted |
| Mar 21, 1984 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Feb 17, 1984 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1984 | Supplement 20Labeling | Approved | None posted |
| Aug 31, 1982 | Supplement 7Labeling | Approved | None posted |
| Jul 26, 1982 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jun 9, 1982 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1982 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jan 8, 1982 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Sep 16, 1981 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1980 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jul 3, 1980 | Supplement 1Labeling | Approved | None posted |
| Jul 3, 1980 | Supplement 2Labeling | Approved | None posted |
| Jun 10, 1980 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jun 6, 1980 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| May 28, 1980 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Feb 22, 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
