Treats recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents…. ANDA 208766, held by Amneal. Acyclovir.
As of Nov 13, 2026, ANDA 208766 (Acyclovir), held by Amneal, was first approved by FDA on Nov 9, 2020, with 1 approved supplement and 0 published complete response letters.
Acyclovir cream, 5% is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 9, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acyclovir5% · cream;topical | Acyclovir | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 1, 2021 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 9, 2020 | Original application | Approved | None posted |
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
