APPLICATION
ANDA078656
TYPE
ANDA
ORIGINAL APPROVAL
2010-05-24
LATEST ACTION
2024-11-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
VALACYCLOVIR HYDROCHLORIDEDiscontinued
VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE · TABLET · ORAL
VALACYCLOVIR HYDROCHLORIDEDiscontinued
VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE · TABLET · ORAL
Approval history
2024-11-19Labeling · Supplement 4 · standardAP
2020-09-10Labeling · Supplement 3 · standardAP
2010-05-24OriginalAP
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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