APPLICATION
ANDA077135
TYPE
ANDA
ORIGINAL APPROVAL
2010-05-24
LATEST ACTION
2023-03-22
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
2023-03-22Labeling · Supplement 13 · standardAP
2023-03-22Labeling · Supplement 11 · standardAP
2015-10-28Labeling · Supplement 6 · 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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