APPLICATION
ANDA077018
TYPE
ANDA
ORIGINAL APPROVAL
2006-06-06
LATEST ACTION
2012-03-28
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription
Products
METRONIDAZOLEPrescription
METRONIDAZOLE 0.75% · GEL · TOPICAL
Approval history
2012-03-28Labeling · Supplement 3AP
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.