FDA ANDA · ANDA078518
VALACYCLOVIR HYDROCHLORIDE
valacyclovir
Sponsor: MYLAN PHARMS 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
ANDA078518
TYPE
ANDA
ORIGINAL APPROVAL
2010-05-24
LATEST ACTION
2026-10-14
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
2026-10-14Labeling · Supplement 17 · standardAP
2023-05-11Labeling · Supplement 6 · standardAP
2015-03-13Manufacturing (CMC) · Supplement 1AP
2013-05-31Labeling · Supplement 3 · standardAP
2010-05-24OriginalAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →