Livostin

NDA 20219, held by Novartis. Levocabastine Hydrochloride.

As of Nov 13, 2026, NDA 20219 (Livostin), held by Novartis, was first approved by FDA on Nov 10, 1993, with 8 approved supplements and 0 published complete response letters.

First approved: Nov 10, 1993
Review: Priority
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below


Jun 10, 1996	Supplement 3Efficacy (new indication or use) · Standard review	Approved	None posted
Nov 10, 1993	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
LivostinEQ 0.05% BASE · suspension/drops;ophthalmic	Levocabastine Hydrochloride	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Dec 26, 2000	Supplement 9Manufacturing · Priority review	Approved	None posted
Feb 23, 1999	Supplement 7Manufacturing · Priority review	Approved	None posted
Dec 2, 1998	Supplement 6Manufacturing · Priority review	Approved	None posted
Apr 30, 1997	Supplement 5Manufacturing · Priority review	Approved	None posted
Aug 14, 1996	Supplement 4Labeling · Standard review	Approved	None posted
Jun 10, 1996	Supplement 3Efficacy (new indication or use) · Standard review	Approved	None posted
Mar 23, 1995	Supplement 2Labeling · Standard review	Approved	None posted
Oct 24, 1994	Supplement 1Labeling · Standard review	Approved	None posted
Nov 10, 1993	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 20219
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