← FDA DRUG APPROVALS

FDA ANDA · ANDA077523

FLUCONAZOLE

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA077523
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-12
LATEST ACTION
2012-01-23
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

FLUCONAZOLEDiscontinued
FLUCONAZOLE 50MG/5ML · FOR SUSPENSION · ORAL
FLUCONAZOLEDiscontinued
FLUCONAZOLE 200MG/5ML · FOR SUSPENSION · ORAL

Approval history

2012-01-23Labeling · Supplement 5AP
2012-01-23Labeling · Supplement 4AP
2010-12-27Labeling · Supplement 3AP
2008-07-23Labeling · Supplement 2AP
2007-09-12OriginalAP
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 →