Treats infected skin cysts and certain other skin abscesses. ANDA 62307, held by Padagis US. Gentamicin Sulfate.
As of Nov 15, 2026, ANDA 62307 (Gentamicin Sulfate), held by Padagis US, was first approved by FDA on May 15, 1981, with 5 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. Please Note: Gentamicin Sulfate is a bactericidal agent that is not effective against viruses or fungi in skin infections.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 15, 1981 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gentamicin SulfateEQ 0.1% BASE · cream;topical | Gentamicin Sulfate | Rx |
| Dec 3, 2009 | Supplement 22Labeling | Approved | None posted |
| Apr 17, 2009 | Supplement 21Labeling | Approved | None posted |
| May 9, 2003 | Supplement 18Labeling | Approved | None posted |
| Sep 18, 2000 | Supplement 16Manufacturing | Approved | None posted |
| May 21, 1993 | Supplement 15Labeling | Approved | None posted |
| May 15, 1981 | 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
