NDA 9276, held by Bowman Pharms. Rauwolfia Serpentina Root.
As of Nov 13, 2026, NDA 9276 (Hiwolfia), held by Bowman Pharms, was first approved by FDA on Jan 28, 1954, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 28, 1954 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hiwolfia50MG · tablet;oral | Rauwolfia Serpentina Root | Discontinued |
| Hiwolfia100MG · tablet;oral | Rauwolfia Serpentina Root | Discontinued |
| Hiwolfia50MG · tablet;oral | Rauwolfia Serpentina Root | Discontinued |
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