NDA 18678, held by Baxter Hlthcare. Amino Acids.
As of Nov 13, 2026, NDA 18678 (Branchamin 4%), held by Baxter Hlthcare, was not approved, with 1 approved supplement and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| Branchamin 4%4% (4GM/100ML) · injectable;injection | Amino Acids | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 26, 1985 | Supplement 1Manufacturing · 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
