Carteolol Hydrochloride

ANDA 75546, held by Bausch And Lomb. Carteolol Hydrochloride.

As of Nov 15, 2026, ANDA 75546 (Carteolol Hydrochloride), held by Bausch And Lomb, was first approved by FDA on Jan 20, 2000, with 7 approved supplements and 0 published complete response letters.

First approved: Jan 20, 2000
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jan 20, 2000	Original application	Approved	Letter

Products

1 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements


Nov 27, 2001	Supplement 8Manufacturing	Approved	None posted
Mar 7, 2001	Supplement 7Manufacturing	Approved	None posted
Oct 5, 2000	Supplement 6Manufacturing	Approved	None posted
Sep 21, 2000	Supplement 4Manufacturing	Approved	None posted
Aug 21, 2000	Supplement 3Manufacturing	Approved	None posted
Jun 27, 2000	Supplement 5Manufacturing	Approved	None posted
May 15, 2000	Supplement 1Manufacturing	Approved	None posted
Jan 20, 2000	Original application	Approved	Letter

Identifiers

Application: ANDA 75546
Drugs@FDA: Overview at FDA
Company: Bausch & Lomb

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