ANDA 61739, held by Schering. Gentamicin Sulfate.
As of Nov 15, 2026, ANDA 61739 (Garamycin), held by Schering, was first approved by FDA on May 3, 1973, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 3, 1973 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| GaramycinEQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ยท injectable;injection | Gentamicin Sulfate | Discontinued |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
