Reduces ammonia-forming bacteria in the intestinal tract. ANDA 204435, held by Chartwell Molecular. Neomycin Sulfate.
As of Nov 15, 2026, ANDA 204435 (Neomycin Sulfate), held by Chartwell Molecular, was first approved by FDA on Jun 10, 2016, with 2 approved supplements 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 and other antibacterial drugs, neomycin sulfate tablets 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 |
|---|---|---|---|
| Jun 10, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Neomycin Sulfate500MG · tablet;oral | Neomycin Sulfate | Discontinued |
| Mar 27, 2025 | Supplement 7Labeling · Standard review | Approved | None posted |
| Feb 10, 2023 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jun 10, 2016 | 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
