← FDA DRUG APPROVALS

FDA ANDA · ANDA076763

CLOTRIMAZOLE

Sponsor: PADAGIS US

APPLICATION
ANDA076763
TYPE
ANDA
ORIGINAL APPROVAL
2005-10-28
LATEST ACTION
2007-09-10
ROUTE
ORAL
DOSAGE FORM
TROCHE/LOZENGE
MARKETING STATUS
Prescription

Products

CLOTRIMAZOLEPrescription
CLOTRIMAZOLE 10MG · TROCHE/LOZENGE · ORAL

Approval history

2007-09-10Labeling · Supplement 6AP
2005-10-28OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →