Treats serious infections due to susceptible strains of Gram-negative bacteria, including…. ANDA 218146, held by Qilu. Amikacin Sulfate.
As of Nov 15, 2026, ANDA 218146 (Amikacin Sulfate), held by Qilu, was first approved by FDA on Mar 19, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Amikacin Sulfate Injection is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella-Enterobacter-Serratia species, and Acinetobacter ( Mima-Herellea ) species.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 19, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amikacin SulfateEQ 250MG BASE/ML · injectable;injection | Amikacin Sulfate | Rx |
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
