NDA 17514, held by Otsuka Icu Medcl. Sodium Chloride.
As of Nov 13, 2026, NDA 17514 (Sodium Chloride 0.9% In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Apr 8, 1974, with 47 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 8, 1974 | 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 | RxReference drug |
| Jun 12, 2014 | Supplement 69Manufacturing · Standard review | Approved | None posted |
| Apr 21, 2004 | Supplement 58Labeling · Standard review | Approved | |
| Feb 10, 1998 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Aug 24, 1993 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Jun 30, 1992 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Nov 25, 1988 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Nov 12, 1986 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1986 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Jan 18, 1986 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1985 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1984 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Aug 25, 1984 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Mar 15, 1984 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Aug 31, 1982 | Supplement 39Labeling | Approved | None posted |
| Jun 10, 1982 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Nov 6, 1981 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Jul 21, 1981 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Mar 5, 1981 | Supplement 40Labeling | Approved | None posted |
| Sep 25, 1980 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Sep 9, 1980 | Supplement 37Labeling | Approved | None posted |
| Jun 6, 1980 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Jun 6, 1980 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| May 28, 1980 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Mar 20, 1980 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Feb 12, 1980 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1979 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Jul 18, 1979 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| May 1, 1979 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Jan 17, 1979 | Supplement 23Labeling | Approved | None posted |
| Jan 5, 1979 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Jan 3, 1979 | Supplement 22Labeling | Approved | None posted |
| Dec 1, 1978 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Nov 22, 1978 | Supplement 19Labeling | Approved | None posted |
| Nov 22, 1978 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Oct 16, 1978 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Jul 12, 1978 | Supplement 16Labeling | Approved | None posted |
| Jul 12, 1978 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jun 27, 1977 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1977 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Apr 20, 1976 | Supplement 12Labeling | Approved | None posted |
| Mar 29, 1976 | Supplement 11Labeling | Approved | None posted |
| Oct 7, 1975 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Sep 4, 1975 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jul 15, 1975 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jul 15, 1975 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Apr 8, 1974 | 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
