ANDA 63169, held by Igi Labs Inc. Amikacin Sulfate.
As of Nov 15, 2026, ANDA 63169 (Amikacin Sulfate), held by Igi Labs Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| Amikacin SulfateEQ 250MG BASE/ML ยท injectable;injection | Amikacin Sulfate | 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
