Vasocon-A

NDA 18746, held by Novartis. Antazoline Phosphate; Naphazoline Hydrochloride.

As of Nov 13, 2026, NDA 18746 (Vasocon-A), held by Novartis, was first approved by FDA on Apr 30, 1990, with 7 approved supplements and 0 published complete response letters.

First approved: Apr 30, 1990
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

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


Jul 11, 1994	Supplement 6Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 30, 1990	Original applicationTYPE 6 · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vasocon-A0.5%;0.05% · solution/drops;ophthalmic	Antazoline Phosphate; Naphazoline Hydrochloride	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Jan 2, 2001	Supplement 11Manufacturing · Standard review	Approved	None posted
Mar 6, 1997	Supplement 9Labeling · Standard review	Approved	None posted
Aug 22, 1995	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 3, 1995	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 13, 1995	Supplement 8Labeling · Standard review	Approved	None posted
Jul 11, 1994	Supplement 6Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 21, 1990	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 30, 1990	Original applicationTYPE 6 · Standard review	Approved	None posted

Identifiers

Application: NDA 18746
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