NDA 18721, held by B Braun. Calcium Chloride; Potassium Chloride; Sodium Chloride.
As of Nov 14, 2026, NDA 18721 (Ringer'S In Plastic Container), held by B Braun, was first approved by FDA on Nov 9, 1982, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 9, 1982 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ringer'S In Plastic Container33MG/100ML;30MG/100ML;860MG/100ML ยท injectable;injection | Calcium Chloride; Potassium Chloride; Sodium Chloride | Discontinued |
| Sep 11, 1990 | Supplement 6Manufacturing | Approved | None posted |
| Jul 30, 1985 | Supplement 4Labeling | Approved | None posted |
| Apr 3, 1985 | Supplement 2Manufacturing | Approved | None posted |
| Apr 3, 1985 | Supplement 3Manufacturing | Approved | None posted |
| Nov 9, 1982 | Original application | 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