ANDA 206561, held by Navinta LLC. Indomethacin Sodium.
As of Nov 15, 2026, ANDA 206561 (Indomethacin Sodium), held by Navinta LLC, was first approved by FDA on Jul 19, 2017, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 19, 2017 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Indomethacin SodiumEQ 1MG BASE/VIAL · injectable;injection | Indomethacin Sodium | Discontinued |
| Sep 7, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jul 19, 2017 | 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
