NDA 219757, held by Rosemont Pharms. Ramipril.
As of Nov 14, 2026, NDA 219757 (Vostally), held by Rosemont Pharms, was first approved by FDA on Jul 23, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 23, 2025 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vostally1MG/ML · solution;oral | Ramipril | DiscontinuedReference 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
