FDA ANDA · ANDA205220
VALGANCICLOVIR HYDROCHLORIDE FOR ORAL
valganciclovir hydrochloride
Sponsor: ACTAVIS LABS FL INC
What this page does not claim
A drug page is a reference view of public FDA data (Drugs@FDA), reproduced as published. SPEQ is not affiliated with the FDA, adds no interpretation to the record, and nothing here is medical, legal, or regulatory advice.
APPLICATION
ANDA205220
TYPE
ANDA
ORIGINAL APPROVAL
2016-07-18
LATEST ACTION
2026-10-19
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription
Products
VALGANCICLOVIR HYDROCHLORIDEPrescription
VALGANCICLOVIR HYDROCHLORIDE 50MG/ML · FOR SOLUTION · ORAL
Approval history
2026-10-19Manufacturing (CMC) · Supplement 17 · unknownAP
2020-03-12Labeling · Supplement 4 · standardAP
2020-03-12Labeling · Supplement 2 · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →