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FDA ANDA · ANDA202362

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE

Sponsor: MYLAN

APPLICATION
ANDA202362
TYPE
ANDA
ORIGINAL APPROVAL
2014-05-27
LATEST ACTION
2019-11-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ATOVAQUONE AND PROGUANIL HYDROCHLORIDEPrescription
ATOVAQUONE 62.5MG, PROGUANIL HYDROCHLORIDE 25MG · TABLET · ORAL
ATOVAQUONE AND PROGUANIL HYDROCHLORIDEPrescription
ATOVAQUONE 250MG, PROGUANIL HYDROCHLORIDE 100MG · TABLET · ORAL

Approval history

2019-11-22Labeling · Supplement 3 · standardAP
2014-05-27UNKNOWN · OriginalAP
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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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