← FDA DRUG APPROVALS

FDA NDA · NDA020925

TAVIST-1

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA020925
TYPE
NDA
ORIGINAL APPROVAL
1992-08-21
LATEST ACTION
2002-06-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TAVIST-1 · ReferenceDiscontinued
CLEMASTINE FUMARATE 1.34MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2002-06-12Manufacturing (CMC) · Supplement 2AP
2000-02-22Manufacturing (CMC) · Supplement 1AP
1992-08-21Type 8 - Partial Rx to OTC Switch · Original · unknownAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →