Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Manages initial genital herpes. NDA 18604, held by Bausch. Acyclovir.
As of Nov 14, 2026, NDA 18604 (Zovirax), held by Bausch, was first approved by FDA on Mar 29, 1982, with 17 approved supplements and 0 published complete response letters.
First approved: Mar 29, 1982
Review: Priority
Supplements approved: 17
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
INDICATIONS AND USAGE ZOVIRAX Ointment 5% is indicated in the management of initial genital herpes and in limited non-lifethreatening mucocutaneous HSV infections in immunocompromised patients.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
