NDA 18186, held by B Braun. Sodium Lactate.
As of Nov 13, 2026, NDA 18186 (Sodium Lactate 0.167 Molar In Plastic Container), held by B Braun, was first approved by FDA on Jun 15, 1979, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 15, 1979 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sodium Lactate 0.167 Molar In Plastic Container1.87GM/100ML ยท injectable;injection | Sodium Lactate | Discontinued |
| Mar 24, 1993 | Supplement 16Labeling | Approved | None posted |
| Sep 11, 1990 | Supplement 15Manufacturing | Approved | None posted |
| Feb 18, 1986 | Supplement 10Manufacturing | Approved | None posted |
| Jun 28, 1985 | Supplement 11Manufacturing | Approved | None posted |
| Jun 24, 1985 | Supplement 13Labeling | Approved | None posted |
| Apr 3, 1985 | Supplement 12Manufacturing | Approved | None posted |
| Jan 24, 1983 | Supplement 7Labeling | Approved | None posted |
| Oct 26, 1981 | Supplement 9Manufacturing | Approved | None posted |
| Feb 24, 1981 | Supplement 8Manufacturing | Approved | None posted |
| Oct 24, 1980 | Supplement 5Manufacturing | Approved | None posted |
| Sep 25, 1980 | Supplement 6Manufacturing | Approved | None posted |
| Aug 6, 1980 | Supplement 4Manufacturing | Approved | None posted |
| Feb 12, 1980 | Supplement 3Manufacturing | Approved | None posted |
| Oct 16, 1979 | Supplement 1Manufacturing | Approved | None posted |
| Oct 9, 1979 | Supplement 2Labeling | Approved | None posted |
| Jun 15, 1979 | 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
