Treats infected skin cysts and certain other skin abscesses. ANDA 62351, held by Padagis US. Gentamicin Sulfate.
As of Nov 15, 2026, ANDA 62351 (Gentamicin Sulfate), held by Padagis US, was first approved by FDA on Feb 18, 1982, with 7 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 |
|---|---|---|---|
| Feb 18, 1982 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gentamicin SulfateEQ 0.1% BASE · ointment;topical | Gentamicin Sulfate | Rx |
| Dec 4, 2009 | Supplement 20Labeling | Approved | None posted |
| Apr 17, 2009 | Supplement 19Labeling | Approved | None posted |
| May 21, 2003 | Supplement 17Labeling | Approved | None posted |
| Nov 26, 2002 | Supplement 16Manufacturing | Approved | None posted |
| Mar 14, 2002 | Supplement 15Manufacturing | Approved | None posted |
| May 21, 1993 | Supplement 14Labeling | Approved | None posted |
| Jul 13, 1987 | Supplement 13Manufacturing | Approved | None posted |
| Feb 18, 1982 | 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
