APPLICATION
ANDA074863
TYPE
ANDA
ORIGINAL APPROVAL
1998-03-13
LATEST ACTION
2002-11-18
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
CLEMASTINE FUMARATEDiscontinued
CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML · SYRUP · ORAL
Approval history
2002-11-18Manufacturing (CMC) · Supplement 1AP
1998-03-13OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.