ANDA 76097, held by Apotex Inc. Carteolol Hydrochloride.
As of Nov 15, 2026, ANDA 76097 (Carteolol Hydrochloride), held by Apotex Inc, was first approved by FDA on Feb 6, 2002, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 6, 2002 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Carteolol Hydrochloride1% ยท solution/drops;ophthalmic | Carteolol Hydrochloride | 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
