APPLICATION
ANDA091114
TYPE
ANDA
ORIGINAL APPROVAL
2011-03-21
LATEST ACTION
2019-07-08
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
2019-07-08Labeling · Supplement 9 · standardAP
2019-07-08Labeling · Supplement 8 · standardAP
2016-03-24Labeling · Supplement 5 · standardAP
2016-03-24Labeling · Supplement 4 · standardAP
2013-07-23Labeling · Supplement 3 · standardAP
2013-05-30Labeling · Supplement 2AP
2011-03-21OriginalAP
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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