NDA 21594, held by Intl Medication Sys. Amiodarone Hydrochloride.
As of Nov 15, 2026, NDA 21594 (Amiodarone Hydrochloride), held by Intl Medication Sys, was first approved by FDA on Feb 4, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 4, 2004 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amiodarone Hydrochloride50MG/ML · injectable;injection | Amiodarone Hydrochloride | Discontinued |
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
