← FDA DRUG APPROVALS

FDA ANDA · ANDA074075

CLEMASTINE FUMARATE

Sponsor: ACTAVIS MID ATLANTIC

APPLICATION
ANDA074075
TYPE
ANDA
ORIGINAL APPROVAL
1993-10-31
LATEST ACTION
2000-12-04
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

CLEMASTINE FUMARATEDiscontinued
CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML · SYRUP · ORAL

Approval history

2000-12-04Manufacturing (CMC) · Supplement 8AP
2000-12-04Manufacturing (CMC) · Supplement 7AP
2000-03-27Manufacturing (CMC) · Supplement 6AP
2000-03-27Manufacturing (CMC) · Supplement 4AP
2000-03-27Labeling · Supplement 5AP
1994-02-08Labeling · Supplement 1AP
1993-10-31OriginalAP
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 →