APPLICATION
ANDA077487
TYPE
ANDA
ORIGINAL APPROVAL
2007-08-24
LATEST ACTION
2019-07-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FAMCICLOVIRPrescription
FAMCICLOVIR 500MG · TABLET · ORAL
FAMCICLOVIRPrescription
FAMCICLOVIR 125MG · TABLET · ORAL
FAMCICLOVIRPrescription
FAMCICLOVIR 250MG · TABLET · ORAL
Approval history
2019-07-08Labeling · Supplement 9 · standardAP
2013-06-27Labeling · Supplement 7 · standardAP
2011-07-29Labeling · Supplement 5AP
2011-05-09Labeling · Supplement 4AP
2009-04-29Labeling · Supplement 3AP
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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