APPLICATION
ANDA206560
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-16
LATEST ACTION
2024-11-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METRONIDAZOLEPrescription
METRONIDAZOLE 250MG · TABLET · ORAL
METRONIDAZOLEPrescription
METRONIDAZOLE 500MG · TABLET · ORAL
Approval history
2024-11-05Labeling · Supplement 10 · standardAP
2024-07-08Labeling · Supplement 9 · standardAP
2024-06-18Labeling · Supplement 8 · standardAP
2023-08-15Labeling · Supplement 6 · standardAP
2021-08-19Labeling · Supplement 3 · standardAP
2019-08-13Labeling · Supplement 2 · standardAP
2016-11-16UNKNOWN · 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.