NDA 17635, held by Otsuka Icu Medcl. Calcium Chloride; Potassium Chloride; Sodium Chloride.
As of Nov 13, 2026, NDA 17635 (Ringer'S In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on May 14, 1976, with 41 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 14, 1976 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ringer'S In Plastic Container33MG/100ML;30MG/100ML;860MG/100ML · solution;irrigation | Calcium Chloride; Potassium Chloride; Sodium Chloride | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 12, 2014 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Feb 28, 2000 | Supplement 45Labeling · Standard review | Approved | None posted |
| Dec 1, 1999 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Feb 4, 1998 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Aug 24, 1993 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Jun 30, 1992 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Dec 27, 1988 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1986 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Jan 18, 1986 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1985 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Nov 9, 1984 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1984 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Aug 25, 1984 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Mar 15, 1984 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Aug 31, 1982 | Supplement 24Labeling | Approved | None posted |
| Jun 18, 1982 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1982 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Nov 6, 1981 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Jul 21, 1981 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Sep 30, 1980 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Sep 25, 1980 | Supplement 22Labeling | Approved | None posted |
| Jun 6, 1980 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Jun 6, 1980 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| May 28, 1980 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| May 23, 1980 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| May 16, 1980 | Supplement 16Labeling | Approved | None posted |
| Mar 20, 1980 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Feb 12, 1980 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Oct 4, 1979 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1979 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jul 18, 1979 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| May 1, 1979 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Feb 2, 1979 | Supplement 6Labeling | Approved | None posted |
| Jan 5, 1979 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1978 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jul 21, 1977 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Apr 26, 1977 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jun 28, 1976 | Supplement 1Labeling | Approved | None posted |
| May 14, 1976 | 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
