NDA 19933, held by Baxter Hlthcare. Calcium Chloride; Potassium Chloride; Sodium Chloride; Sodium Lactate.
As of Nov 14, 2026, NDA 19933 (Lactated Ringer'S In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Aug 29, 1989, with 8 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 29, 1989 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lactated Ringer'S In Plastic Container20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML · solution;irrigation | Calcium Chloride; Potassium Chloride; Sodium Chloride; Sodium Lactate | Discontinued |
| Jun 15, 2007 | Supplement 10Manufacturing | Approved | None posted |
| Aug 14, 2001 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Dec 7, 2000 | Supplement 6Labeling · Standard review | Approved | None posted |
| Sep 30, 1994 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Feb 18, 1994 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Oct 5, 1993 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Apr 26, 1991 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Mar 26, 1991 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1989 | 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
