APPLICATION
ANDA077478
TYPE
ANDA
ORIGINAL APPROVAL
2010-05-24
LATEST ACTION
2023-03-31
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
2023-03-31Labeling · Supplement 14 · standardAP
2020-10-26Labeling · Supplement 13 · standardAP
2013-02-01Labeling · Supplement 8 · 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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