Treats external infections of the eye and its adnexa caused by susceptible bacteria. ANDA 211847, held by Alembic. Tobramycin.
As of Nov 15, 2026, ANDA 211847 (Tobramycin), held by Alembic, was first approved by FDA on Apr 19, 2019, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Tobramycin ophthalmic solution, 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. Clinical studies have shown tobramycin to be safe and effective for use in children.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 19, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tobramycin0.3% · solution/drops;ophthalmic | Tobramycin | Rx |
| Jul 7, 2021 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 7, 2021 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 19, 2019 | 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
