APPLICATION
ANDA215794
TYPE
ANDA
ORIGINAL APPROVAL
2022-01-27
LATEST ACTION
2023-02-06
ROUTE
VAGINAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription
Products
METRONIDAZOLEPrescription
METRONIDAZOLE 0.75% · GEL · VAGINAL
Approval history
2023-02-06Manufacturing (CMC) · Supplement 1 · unknownAP
2022-01-27UNKNOWN · Original · standardAP
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.