ANDA 204118, held by Hospira. Indomethacin Sodium.
As of Nov 15, 2026, ANDA 204118 (Indomethacin Sodium), held by Hospira, was first approved by FDA on Apr 19, 2016, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 19, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Indomethacin SodiumEQ 1MG BASE/VIAL · injectable;injection | Indomethacin Sodium | Discontinued |
| May 30, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Apr 19, 2016 | 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
