APPLICATION
ANDA209750
TYPE
ANDA
ORIGINAL APPROVAL
2017-10-11
LATEST ACTION
2019-09-20
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
ATOVAQUONEDiscontinued
ATOVAQUONE 750MG/5ML · SUSPENSION · ORAL
Approval history
2019-09-20Labeling · Supplement 4 · standardAP
2019-09-20Labeling · Supplement 3 · standardAP
2018-12-21Labeling · Supplement 1 · standardAP
2017-10-11UNKNOWN · 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.