NDA 18386, held by B Braun. Dextrose; Sodium Chloride.
As of Nov 13, 2026, NDA 18386 (Dextrose 10% And Sodium Chloride 0.2% In Plastic Container), held by B Braun, was first approved by FDA on Jul 11, 1980, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 11, 1980 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dextrose 10% And Sodium Chloride 0.2% In Plastic Container10GM/100ML;200MG/100ML · injectable;injection | Dextrose; Sodium Chloride | Discontinued |
| Sep 11, 1990 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Feb 18, 1986 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jun 28, 1985 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| May 24, 1985 | Supplement 10Labeling · Standard review | Approved | None posted |
| Apr 3, 1985 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Dec 10, 1984 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jan 24, 1983 | Supplement 4Labeling · Standard review | Approved | None posted |
| Oct 26, 1981 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Dec 12, 1980 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Dec 10, 1980 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Oct 7, 1980 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jul 11, 1980 | 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
