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Manages initial genital herpes. ANDA 209000, held by Alembic. Acyclovir.
As of Nov 13, 2026, ANDA 209000 (Acyclovir), held by Alembic, was first approved by FDA on Apr 6, 2018, with 1 approved supplement and 0 published complete response letters.
First approved: Apr 6, 2018
Review: Standard
Supplements approved: 1
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 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
