APPLICATION
ANDA203047
TYPE
ANDA
ORIGINAL APPROVAL
2015-04-08
LATEST ACTION
2026-06-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VALACYCLOVIR HYDROCHLORIDEPrescription
VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE · TABLET · ORAL
VALACYCLOVIR HYDROCHLORIDEPrescription
VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE · TABLET · ORAL
Approval history
2026-06-10Labeling · Supplement 20 · standardAP
2023-02-23Labeling · Supplement 14 · standardAP
2023-02-23Labeling · Supplement 12 · standardAP
2015-10-26Labeling · Supplement 1 · standardAP
2015-04-08UNKNOWN · OriginalAP
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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