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FDA ANDA · ANDA091211

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC

Sponsor: GLENMARK PHARMS LTD

APPLICATION
ANDA091211
TYPE
ANDA
ORIGINAL APPROVAL
2011-01-12
LATEST ACTION
2019-11-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2019-11-22Labeling · Supplement 9 · standardAP
2014-06-04Labeling · Supplement 3 · standardAP
2011-01-12OriginalAP
VIEW ON DRUGS@FDA ↗

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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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