Treats serious infections due to susceptible strains of Gram-negative bacteria, including…. ANDA 204040, held by Avet Lifesciences. Amikacin Sulfate.
As of Nov 15, 2026, ANDA 204040 (Amikacin Sulfate), held by Avet Lifesciences, was first approved by FDA on Dec 12, 2013, with 5 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Amikacin Sulfate Injection USP 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 |
|---|---|---|---|
| Dec 12, 2013 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amikacin SulfateEQ 250MG BASE/ML · injectable;injection | Amikacin Sulfate | Rx |
| Feb 10, 2023 | Supplement 21Labeling · Standard review | Approved | None posted |
| Dec 13, 2019 | Supplement 5Labeling · Standard review | Approved | None posted |
| Dec 13, 2019 | Supplement 10Labeling · Standard review | Approved | None posted |
| Dec 13, 2019 | Supplement 14Labeling · Standard review | Approved | None posted |
| Jun 14, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 12, 2013 | 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
