Treats serious infections due to susceptible strains of Gram-negative bacteria, including…. ANDA 203323, held by Sagent Pharms Inc. Amikacin Sulfate.
As of Nov 15, 2026, ANDA 203323 (Amikacin Sulfate), held by Sagent Pharms Inc, was first approved by FDA on May 12, 2016, with 2 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 |
|---|---|---|---|
| May 12, 2016 | Original application | Approved | None posted |
| Amikacin SulfateEQ 250MG BASE/ML · injectable;injection | Amikacin Sulfate | Rx |
| Amikacin Sulfate500MG(BASE)/ML(250MG/ML) · injectable;injection | Amikacin Sulfate | Rx |
| Amikacin Sulfate1G(BASE)/4ML(250MG/ML) · injectable;injection | Amikacin Sulfate | Rx |
| Feb 10, 2023 | Supplement 7Labeling · Standard review | Approved | None posted |
| May 12, 2016 | Original application | Approved | None posted |
| May 12, 2016 | Supplement 12Manufacturing | 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
