Ocupress

NDA 19972, held by Novartis. Carteolol Hydrochloride.

As of Nov 13, 2026, NDA 19972 (Ocupress), held by Novartis, was first approved by FDA on May 23, 1990, with 18 approved supplements and 0 published complete response letters.

First approved: May 23, 1990
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
May 23, 1990	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ocupress1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution/drops;ophthalmic	Carteolol Hydrochloride	DiscontinuedReference drug

All 19 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 22, 2001	Supplement 18Manufacturing · Standard review	Approved	None posted
Mar 29, 2001	Supplement 17Manufacturing · Standard review	Approved	None posted
Dec 26, 2000	Supplement 16Manufacturing · Standard review	Approved	None posted
Dec 18, 1998	Supplement 15Manufacturing · Standard review	Approved	None posted
Nov 24, 1997	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 20, 1997	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 22, 1996	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 6, 1996	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 6, 1996	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 31, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
May 20, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
May 20, 1996	Supplement 6Manufacturing · Standard review	Approved	None posted
May 20, 1996	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 16, 1996	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 1, 1996	Supplement 9Manufacturing · Standard review	Approved	None posted
Mar 18, 1996	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 18, 1996	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 20, 1994	Supplement 1Labeling · Standard review	Approved	None posted
May 23, 1990	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19972
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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