APPLICATION
ANDA076392
TYPE
ANDA
ORIGINAL APPROVAL
2003-12-29
LATEST ACTION
2016-10-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MEFLOQUINE HYDROCHLORIDEPrescription
MEFLOQUINE HYDROCHLORIDE 250MG · TABLET · ORAL
Approval history
2016-10-11Labeling · Supplement 9 · standardAP
2011-09-20Labeling · Supplement 5AP
2009-11-18Labeling · Supplement 4AP
2009-06-12Labeling · Supplement 3AP
2003-12-29OriginalAP
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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