APPLICATION
ANDA203511
TYPE
ANDA
ORIGINAL APPROVAL
2014-11-04
LATEST ACTION
2024-05-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VALGANCICLOVIR HYDROCHLORIDEPrescription
VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE · TABLET · ORAL
Approval history
2024-05-23Labeling · Supplement 8 · standardAP
2024-05-23Labeling · Supplement 6 · standardAP
2020-03-13Labeling · Supplement 4 · standardAP
2020-03-13Labeling · Supplement 3 · standardAP
2016-08-22Labeling · Supplement 1 · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.