ANDA 62288, held by Bristol. Gentamicin Sulfate.
As of Nov 15, 2026, ANDA 62288 (Bristagen), held by Bristol, was not approved, with 0 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| BristagenEQ 40MG BASE/ML ยท injectable;injection | Gentamicin Sulfate | Discontinued |
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
