ANDA 217134, held by Hainan Poly. Iopamidol.
As of Nov 15, 2026, ANDA 217134 (Iopamidol), held by Hainan Poly, was first approved by FDA on Sep 27, 2023, with 1 approved supplement and 0 published complete response letters.
Iopamidol Injection, USP is a radiographic contrast agent indicated for: Intra-arterial Procedures * Cerebral arteriography in adults Peripheral arteriography in adults Selective visceral arteriography and aortography in adults Coronary arteriography and cardiac ventriculography in adults Angiocardiography in pediatric patients Intravenous Procedures * Excretory urography in adults and pediatric patients Computed tomography (CT) of head and body in adults and pediatric patients Peripheral venography in adults * Specific concentrations are recommended for each type of imaging procedure. ( 2.2, 2.3, 2.4 ) 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 27, 2023 | Original application | Approved |
| Apr 9, 2024 | Supplement 1Manufacturing | Approved | None posted |
| Sep 27, 2023 | Original application | Approved |
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
