Tavist Allergy/Sinus/Headache

NDA 21082, held by Novartis. Acetaminophen; Clemastine Fumarate; Pseudoephedrine Hydrochloride.

As of Nov 15, 2026, NDA 21082 (Tavist Allergy/Sinus/Headache), held by Novartis, was first approved by FDA on Mar 1, 2001, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 1, 2001
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
Mar 1, 2001	Original applicationNew combination · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tavist Allergy/Sinus/Headache500MG;EQ 0.25MG BASE;30MG · tablet;oral	Acetaminophen; Clemastine Fumarate; Pseudoephedrine Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jun 12, 2002	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 3, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 1, 2001	Original applicationNew combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21082
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