NDA 214988, held by Be Pharms. Dehydrated Alcohol.
As of Nov 14, 2026, NDA 214988 (Dehydrated Alcohol), held by Be Pharms, was first approved by FDA on Oct 23, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 23, 2025 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dehydrated Alcohol98% (5ML) · solution;intravenous | Dehydrated Alcohol | RxReference drug |
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
