ANDA 64163, held by Pharmobedient. Gentamicin Sulfate.
As of Nov 15, 2026, ANDA 64163 (Gentak), held by Pharmobedient, was first approved by FDA on Oct 12, 2001, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Gentamicin Sulfate Sterile Ophthalmic Solution is indicated in the topical treatment of ocular bacterial infections, including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, 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 |
|---|---|---|---|
| Oct 12, 2001 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| GentakEQ 0.3% BASE · solution/drops;ophthalmic | 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
