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Manages initial genital herpes. ANDA 209971, held by Torrent. Acyclovir.
As of Nov 13, 2026, ANDA 209971 (Acyclovir), held by Torrent, was first approved by FDA on Jan 11, 2019, with 0 approved supplements and 0 published complete response letters.
First approved: Jan 11, 2019
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 non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised 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
