Treats external infections of the eye and its adnexa caused by susceptible bacteria. ANDA 64096, held by Epic Pharma LLC. Tobramycin.
As of Nov 15, 2026, ANDA 64096 (Aktob), held by Epic Pharma LLC, was first approved by FDA on Jan 31, 1996, with 6 approved supplements 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 pediatric patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 31, 1996 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aktob0.3% · solution/drops;ophthalmic | Tobramycin | Discontinued |
| Aug 16, 2021 | Supplement 14Labeling · Standard review | Approved | None posted |
| Jul 11, 2012 | Supplement 5Labeling | Approved | None posted |
| Jun 5, 2001 | Supplement 3Manufacturing | Approved | None posted |
| Jun 7, 1999 | Supplement 4Manufacturing | Approved | None posted |
| Mar 19, 1997 | Supplement 1Manufacturing | Approved | None posted |
| Mar 19, 1997 | Supplement 2Manufacturing | Approved | None posted |
| Jan 31, 1996 | 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
