Treats ocular bacterial infections including conjunctivitis, keratitis…. ANDA 64093, held by Sciegen Pharms. Gentamicin Sulfate.
As of Nov 15, 2026, ANDA 64093 (Gentamicin Sulfate), held by Sciegen Pharms, was first approved by FDA on Aug 31, 1995, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Gentamicin sulfate ophthalmic ointment is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharonconjunctivitis: acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 31, 1995 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gentamicin SulfateEQ 0.3% BASE · ointment;ophthalmic | Gentamicin Sulfate | Discontinued |
| Mar 10, 2017 | Supplement 11Manufacturing | Approved | None posted |
| Apr 27, 1999 | Supplement 3Manufacturing | Approved | None posted |
| Jun 24, 1996 | Supplement 2Manufacturing | Approved | None posted |
| Dec 28, 1995 | Supplement 1Manufacturing | Approved | None posted |
| Aug 31, 1995 | 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
