Manages initial genital herpes. ANDA 205510, held by Glenmark Speclt. Acyclovir.
As of Nov 14, 2026, ANDA 205510 (Acyclovir), held by Glenmark Speclt, was first approved by FDA on Jul 31, 2017, with 0 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 31, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acyclovir5% · ointment;topical | Acyclovir | Rx |
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
