APPLICATION
ANDA077547
TYPE
ANDA
ORIGINAL APPROVAL
2006-07-13
LATEST ACTION
2015-06-14
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription
Products
METRONIDAZOLEPrescription
METRONIDAZOLE 0.75% · GEL · TOPICAL
Approval history
2015-06-14Labeling · Supplement 9 · standardAP
2006-07-13OriginalAP
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.