Treats infected skin cysts and certain other skin abscesses. ANDA 64054, held by Cosette Pharms Nc. Gentamicin Sulfate.
As of Nov 15, 2026, ANDA 64054 (Gentamicin Sulfate), held by Cosette Pharms Nc, was first approved by FDA on Apr 29, 1994, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Primary skin infections: Impetigo contagiosa, superficial folliculitis, ecthyma, furunculosis, sycosis barbae, and pyoderma gangrenosum. Secondary skin infections: Infectious eczematoid dermatitis, pustular acne, pustular psoriasis, infected seborrheic dermatitis, infected contact dermatitis (including poison ivy), infected excoriations, and bacterial superinfections of fungal or viral infections. NOTE: Gentamicin Sulfate is a bactericidal agent that is not effective against viruses or fungi in skin infections.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 1994 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gentamicin SulfateEQ 0.1% BASE · ointment;topical | Gentamicin Sulfate | Rx |
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
