APPLICATION
ANDA090128
TYPE
ANDA
ORIGINAL APPROVAL
2011-03-21
LATEST ACTION
2019-07-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
FAMCICLOVIRDiscontinued
FAMCICLOVIR 250MG · TABLET · ORAL
FAMCICLOVIRDiscontinued
FAMCICLOVIR 500MG · TABLET · ORAL
FAMCICLOVIRDiscontinued
FAMCICLOVIR 125MG · TABLET · ORAL
Approval history
2019-07-25Labeling · Supplement 4 · standardAP
2019-07-25Labeling · Supplement 5 · standardAP
2016-03-25Labeling · Supplement 3 · standardAP
2013-04-23Labeling · Supplement 2 · standardAP
2011-08-02Labeling · Supplement 1AP
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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