NDA 19864, held by B Braun. Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride.
As of Nov 13, 2026, NDA 19864 (Isolyte R In Dextrose 5% In Plastic Container), held by B Braun, was first approved by FDA on Jun 10, 1993, with 7 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 10, 1993 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Isolyte R In Dextrose 5% In Plastic Container37MG/100ML;5GM/100ML;31MG/100ML;120MG/100ML;330MG/100ML;88MG/100ML · injectable;injection | Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 1, 2002 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Apr 15, 2002 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Dec 7, 2000 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Aug 21, 1998 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1995 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Sep 13, 1995 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jun 1, 1994 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 10, 1993 | 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
