APPLICATION
ANDA212918
TYPE
ANDA
ORIGINAL APPROVAL
2021-03-30
LATEST ACTION
2021-03-30
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
ATOVAQUONEPrescription
ATOVAQUONE 750MG/5ML · SUSPENSION · ORAL
Approval history
2021-03-30UNKNOWN · 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.