Used in scans for known or suspected coronary artery disease (CAD) 1.1 Magnetic Resonance Imaging (MRI) of the Central Nervous System (CNS). ANDA 217480, held by Hainan Poly Pharm. Gadobutrol.
As of Nov 15, 2026, ANDA 217480 (Gadobutrol), held by Hainan Poly Pharm, was first approved by FDA on Mar 15, 2023, with 1 approved supplement and 0 published complete response letters.
Gadobutrol injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI): To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients (including term neonates) To assess the presence and extent of malignant breast disease in adult patients To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients (including term neonates) To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD) 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 15, 2023 | Original application | Approved | None posted |
| Gadobutrol4.5354GM/7.5ML (604.72MG/ML) · solution;intravenous | Gadobutrol | Rx |
| Gadobutrol9.0708GM/15ML (604.72MG/ML) · solution;intravenous | Gadobutrol | Rx |
| Gadobutrol1.20944GM/2ML (604.72MG/ML) · solution;intravenous | Gadobutrol | Rx |
| Gadobutrol6.0472GM/10ML (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 |
| Apr 16, 2025 | Supplement 4Manufacturing | Approved | None posted |
| Mar 15, 2023 | Original application | 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
