APPLICATION
ANDA213820
TYPE
ANDA
ORIGINAL APPROVAL
2020-11-27
LATEST ACTION
2022-08-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NITAZOXANIDEPrescription
NITAZOXANIDE 500MG · TABLET · ORAL
Approval history
2022-08-11Labeling · Supplement 2 · standardAP
2021-11-12Manufacturing (CMC) · Supplement 1 · unknownAP
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.