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Manages initial genital herpes. ANDA 212202, held by Prinston. Acyclovir.
As of Nov 13, 2026, ANDA 212202 (Acyclovir), held by Prinston, was first approved by FDA on Nov 15, 2021, with 0 approved supplements and 0 published complete response letters.
First approved: Nov 15, 2021
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 5% is indicated in the management of initial genital herpes and in limited nonlifethreatening mucocutaneous HSV infections in immune compromised patients.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
