APPLICATION
ANDA210692
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-11
LATEST ACTION
2026-06-08
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
ATOVAQUONEPrescription
ATOVAQUONE 750MG/5ML · SUSPENSION · ORAL
Approval history
2026-06-08Labeling · Supplement 6 · standardAP
2024-04-02Labeling · Supplement 3 · standardAP
2018-10-11UNKNOWN · 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.
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