APPLICATION
ANDA201022
TYPE
ANDA
ORIGINAL APPROVAL
2012-01-12
LATEST ACTION
2023-06-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FAMCICLOVIRPrescription
FAMCICLOVIR 250MG · TABLET · ORAL
FAMCICLOVIRPrescription
FAMCICLOVIR 500MG · TABLET · ORAL
FAMCICLOVIRPrescription
FAMCICLOVIR 125MG · TABLET · ORAL
Approval history
2023-06-07Labeling · Supplement 33 · standardAP
2019-07-25Labeling · Supplement 22 · standardAP
2019-07-25Labeling · Supplement 14 · standardAP
2015-11-19Labeling · Supplement 6 · standardAP
2013-05-30Labeling · Supplement 1 · standardAP
2013-05-30Labeling · Supplement 2 · standardAP
2012-01-12Not Applicable · OriginalAP
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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