NDA 16693, held by Baxter Hlthcare. Calcium Chloride; Potassium Chloride; Sodium Chloride.
As of Nov 13, 2026, NDA 16693 (Ringer'S In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Mar 22, 1971, with 69 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 22, 1971 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ringer'S In Plastic Container33MG/100ML;30MG/100ML;860MG/100ML · injectable;injection | Calcium Chloride; Potassium Chloride; Sodium Chloride | Rx |
| Feb 21, 2019 | Supplement 101Labeling · Standard review | Approved | |
| Apr 27, 2016 | Supplement 98Labeling · Standard review | Approved | |
| Sep 30, 2014 | Supplement 97Manufacturing · Standard review | Approved | None posted |
| Sep 11, 2013 | Supplement 96Labeling · Standard review | Approved | |
| Apr 3, 2002 | Supplement 84Labeling · Standard review | Approved | |
| Aug 14, 2001 | Supplement 87Manufacturing · Standard review | Approved | None posted |
| Nov 2, 2000 | Supplement 86Labeling · Standard review | Approved | None posted |
| Nov 24, 1999 | Supplement 85Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1997 | Supplement 83Manufacturing · Standard review | Approved | None posted |
| Sep 30, 1994 | Supplement 81Manufacturing · Standard review | Approved | None posted |
| Feb 18, 1994 | Supplement 82Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1991 | Supplement 78Manufacturing · Standard review | Approved | None posted |
| Mar 26, 1991 | Supplement 77Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1991 | Supplement 76Manufacturing · Standard review | Approved | None posted |
| Jan 22, 1991 | Supplement 79Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1989 | Supplement 75Manufacturing · Standard review | Approved | None posted |
| Jul 25, 1987 | Supplement 74Manufacturing · Standard review | Approved | None posted |
| May 28, 1987 | Supplement 73Manufacturing · Standard review | Approved | None posted |
| Feb 27, 1986 | Supplement 71Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1985 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1985 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Jul 3, 1985 | Supplement 69Labeling | Approved | None posted |
| Jun 13, 1985 | Supplement 68Manufacturing · Standard review | Approved | None posted |
| Apr 15, 1985 | Supplement 70Manufacturing · Standard review | Approved | None posted |
| Jan 24, 1985 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Sep 22, 1984 | Supplement 67Manufacturing · Standard review | Approved | None posted |
| Mar 16, 1984 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1984 | Supplement 66Manufacturing · Standard review | Approved | None posted |
| Jul 11, 1983 | Supplement 58Labeling | Approved | None posted |
| Jun 3, 1982 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1982 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Feb 16, 1982 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Dec 21, 1981 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Nov 20, 1981 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Nov 9, 1981 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Aug 26, 1981 | Supplement 52Labeling | Approved | None posted |
| Jun 29, 1981 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1981 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Jan 21, 1981 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Aug 7, 1980 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1980 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Jun 28, 1980 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Jun 18, 1980 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| May 30, 1980 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1980 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Aug 2, 1979 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Oct 20, 1978 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Aug 7, 1978 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Aug 2, 1978 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Jun 20, 1978 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Apr 25, 1978 | Supplement 34Labeling | Approved | None posted |
| Mar 24, 1978 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Mar 22, 1978 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1978 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Feb 21, 1978 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Dec 14, 1977 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Jun 6, 1977 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Feb 7, 1977 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Dec 21, 1976 | Supplement 18Labeling | Approved | None posted |
| Jul 13, 1976 | Supplement 24Labeling | Approved | None posted |
| Jul 1, 1976 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Jun 17, 1976 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| May 11, 1976 | Supplement 16Labeling | Approved | None posted |
| Jan 5, 1976 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Jan 2, 1976 | Supplement 21Labeling | Approved | None posted |
| Sep 23, 1975 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Sep 17, 1975 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jul 10, 1975 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jun 16, 1975 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Mar 22, 1971 | 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
