Tavist

NDA 18675, held by Novartis. Clemastine Fumarate.

As of Nov 13, 2026, NDA 18675 (Tavist), held by Novartis, was first approved by FDA on Jun 28, 1985, with 6 approved supplements and 0 published complete response letters.

First approved: Jun 28, 1985
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jun 28, 1985	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
TavistEQ 0.5MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · syrup;oral	Clemastine Fumarate	DiscontinuedReference drug

All 7 submissions, including labeling and manufacturing supplements


Feb 11, 2002	Supplement 10Manufacturing · Standard review	Approved	None posted
Jun 14, 1995	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 30, 1994	Supplement 6Labeling · Standard review	Approved	None posted
Jul 21, 1994	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 4, 1987	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 2, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 28, 1985	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18675
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