Treats external infections of the eye and its adnexa caused by susceptible bacteria. ANDA 212628, held by Gland. Tobramycin.
As of Nov 15, 2026, ANDA 212628 (Tobramycin), held by Gland, was first approved by FDA on Mar 9, 2021, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Tobramycin ophthalmic solution USP, 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin ophthalmic solution USP, 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 9, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tobramycin0.3% · solution/drops;ophthalmic | Tobramycin | Rx |
| Jul 13, 2021 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 9, 2021 | 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
