ANDA 215382, held by Hainan Poly. Iopamidol.
As of Nov 15, 2026, ANDA 215382 (Iopamidol), held by Hainan Poly, was first approved by FDA on Feb 27, 2023, with 0 approved supplements and 0 published complete response letters.
Iopamidol injection for intrathecal administration is indicated for: Lumbar and thoracic myelography, and computed tomography (CT) myelography in adults and pediatric patients aged 2 years and older Cervical and total columnar myelography and CT myelography in adults CT cisternography in adults Specific concentrations of iopamidol injection are recommended for each type of imaging procedure.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 27, 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
