Treats recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents…. ANDA 208702, held by Padagis Israel. Acyclovir.
As of Nov 14, 2026, ANDA 208702 (Acyclovir), held by Padagis Israel, was first approved by FDA on Feb 4, 2019, with 1 approved supplement and 0 published complete response letters.
Acyclovir cream 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 |
|---|---|---|---|
| Feb 4, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acyclovir5% · cream;topical | Acyclovir | Rx |
| Nov 2, 2021 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 4, 2019 | Original application | Approved |
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
