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Manages initial genital herpes. ANDA 201501, held by Xiromed. Acyclovir.
As of Nov 14, 2026, ANDA 201501 (Acyclovir), held by Xiromed, was first approved by FDA on Jan 29, 2020, with 0 approved supplements and 0 published complete response letters.
First approved: Jan 29, 2020
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
INDICATIONS AND USAGE Acyclovir Ointment USP, 5% is indicated in the management of initial genital herpes and in limited non-life-threatening 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
