ANDA 65468, held by Pharmobedient. Neomycin Sulfate.
As of Nov 15, 2026, ANDA 65468 (Neomycin Sulfate), held by Pharmobedient, was first approved by FDA on Mar 29, 2010, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 29, 2010 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Neomycin Sulfate500MG · tablet;oral | Neomycin Sulfate | Discontinued |
| Feb 10, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Nov 26, 2014 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 29, 2010 | 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
