ANDA 75473, held by Apotex Inc. Levobunolol Hydrochloride.
As of Nov 15, 2026, ANDA 75473 (Levobunolol Hydrochloride), held by Apotex Inc, was first approved by FDA on Aug 3, 2000, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 3, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levobunolol Hydrochloride0.25% ยท solution/drops;ophthalmic | Levobunolol Hydrochloride | Discontinued |
| Jul 30, 2001 | Supplement 2Manufacturing | Approved | None posted |
| Jan 24, 2001 | Supplement 1Manufacturing | Approved | None posted |
| Aug 3, 2000 | Original application | Approved |
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
