ANDA 65087, held by Apotex Inc. Tobramycin.
As of Nov 15, 2026, ANDA 65087 (Tobramycin), held by Apotex Inc, was first approved by FDA on Feb 25, 2002, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 25, 2002 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tobramycin0.3% ยท solution/drops;ophthalmic | Tobramycin | Discontinued |
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
