APPLICATION
ANDA205245
TYPE
ANDA
ORIGINAL APPROVAL
2015-09-23
LATEST ACTION
2024-10-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METRONIDAZOLEPrescription
METRONIDAZOLE 250MG · TABLET · ORAL
METRONIDAZOLEPrescription
METRONIDAZOLE 500MG · TABLET · ORAL
Approval history
2024-10-25Labeling · Supplement 13 · standardAP
2024-07-08Labeling · Supplement 12 · standardAP
2024-06-18Labeling · Supplement 9 · standardAP
2024-06-18Labeling · Supplement 11 · standardAP
2021-08-18Labeling · Supplement 8 · standardAP
2019-07-29Labeling · Supplement 4 · standardAP
2015-09-23UNKNOWN · 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.