ANDA 219146, held by Zenara. Gadobutrol.
As of Nov 15, 2026, ANDA 219146 (Gadobutrol), held by Zenara, was first approved by FDA on Jun 8, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 8, 2026 | Original application | Approved | None posted |
| Gadobutrol1.20944GM/2ML (604.72MG/ML) · solution;intravenous | Gadobutrol | Rx |
| Gadobutrol4.5354GM/7.5ML (604.72MG/ML) · solution;intravenous | Gadobutrol | Rx |
| Gadobutrol6.0472GM/10ML (604.72MG/ML) · solution;intravenous | Gadobutrol | Rx |
| Gadobutrol9.0708GM/15ML (604.72MG/ML) · solution;intravenous | Gadobutrol | Rx |
| Gadobutrol18.1416GM/30ML (604.72MG/ML) · solution;intravenous | Gadobutrol | Rx |
| Gadobutrol39.3068GM/65ML (604.72MG/ML) · solution;intravenous | Gadobutrol | Rx |
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
