Reduces ammonia-forming bacteria in the intestinal tract. ANDA 65220, held by Amvika. Neomycin Sulfate.
As of Nov 15, 2026, ANDA 65220 (Neomycin Sulfate), held by Amvika, was first approved by FDA on Jul 28, 2006, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Neomycin Sulfate Tablets, USP and other antibacterial drugs, Neomycin Sulfate Tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 28, 2006 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Neomycin Sulfate500MG · tablet;oral | Neomycin Sulfate | Rx |
| Feb 10, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jul 28, 2006 | 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
