Gadoterate Meglumine
ANDA 215304, held by Hengrui Pharma. Gadoterate Meglumine.
- First approved: Apr 11, 2022
- Review: Standard
- Supplements approved: 0
- Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 11, 2022 | Original application | Approved | None posted |
Products
5 strengths and forms| Product | Active ingredient | Marketing |
|---|---|---|
| Gadoterate Meglumine1.8845GM/5ML (376.9MG/ML) · solution;intravenous | Gadoterate Meglumine | Discontinued |
| Gadoterate Meglumine3.769GM/10ML (376.9MG/ML) · solution;intravenous | Gadoterate Meglumine | Discontinued |
| Gadoterate Meglumine5.6535GM/15ML (376.9MG/ML) · solution;intravenous | Gadoterate Meglumine | Discontinued |
| Gadoterate Meglumine7.538GM/20ML (376.9MG/ML) · solution;intravenous | Gadoterate Meglumine | Discontinued |
| Gadoterate Meglumine37.69GM/100ML (376.9MG/ML) · solution;intravenous | Gadoterate Meglumine | Discontinued |
Identifiers
- Application
- ANDA 215304
- Drugs@FDA
- Overview at FDA
- Company
- Hengrui Pharma
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters