Cartrol

NDA 19204, held by Abbvie. Carteolol Hydrochloride.

As of Nov 13, 2026, NDA 19204 (Cartrol), held by Abbvie, was first approved by FDA on Dec 28, 1988, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 28, 1988
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Dec 28, 1988	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
Cartrol2.5MG · tablet;oral	Carteolol Hydrochloride	Discontinued
Cartrol5MG · tablet;oral	Carteolol Hydrochloride	Discontinued
Cartrol10MG · tablet;oral	Carteolol Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 16, 1998	Supplement 2Manufacturing · Standard review	Approved	None posted
Sep 20, 1990	Supplement 1Labeling · Standard review	Approved	None posted
Dec 28, 1988	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19204
Drugs@FDA: Overview at FDA
Company: AbbVie

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