APPLICATION
ANDA202960
TYPE
ANDA
ORIGINAL APPROVAL
2014-03-18
LATEST ACTION
2019-09-20
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
ATOVAQUONEPrescription
ATOVAQUONE 750MG/5ML · SUSPENSION · ORAL
Approval history
2019-09-20Labeling · Supplement 9 · standardAP
2019-09-20Labeling · Supplement 7 · standardAP
2018-12-21Labeling · Supplement 2 · standardAP
2018-12-21Labeling · Supplement 5 · 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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