ANDA 62340, held by Pharm Spec. Gentamicin Sulfate.
As of Nov 15, 2026, ANDA 62340 (Gentamicin Sulfate), held by Pharm Spec, was first approved by FDA on Mar 28, 1983, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 28, 1983 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gentamicin SulfateEQ 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
