Carteolol Hydrochloride

For chronic open-angle glaucoma and intraocular hypertension. ANDA 75476, held by Sandoz. Carteolol Hydrochloride.

As of Nov 15, 2026, ANDA 75476 (Carteolol Hydrochloride), held by Sandoz, was first approved by FDA on Jan 3, 2000, with 5 approved supplements and 0 published complete response letters.

First approved: Jan 3, 2000
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Carteolol Hydrochloride Ophthalmic Solution 1% has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma and intraocular hypertension. It may be used alone or in combination with other intraocular pressure lowering medications.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jan 3, 2000	Original application	Approved	Letter Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Carteolol Hydrochloride1% · solution/drops;ophthalmic	Carteolol Hydrochloride	Rx

All 6 submissions, including labeling and manufacturing supplements


Dec 23, 2002	Supplement 5Manufacturing	Approved	None posted
Oct 1, 2002	Supplement 4Manufacturing	Approved	None posted
Mar 22, 2002	Supplement 3Manufacturing	Approved	None posted
May 1, 2001	Supplement 1Labeling	Approved	None posted
May 1, 2001	Supplement 2Manufacturing	Approved	None posted
Jan 3, 2000	Original application	Approved	Letter Letter

Identifiers

Application: ANDA 75476
Drugs@FDA: Overview at FDA
Company: Sandoz

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