Treats recurrent herpes labialis (cold sores). ANDA 214100, held by Amneal. Penciclovir.
As of Nov 14, 2026, ANDA 214100 (Penciclovir), held by Amneal, was first approved by FDA on Aug 22, 2025, with 0 approved supplements and 0 published complete response letters.
Penciclovir cream, 1% is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age or older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 22, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Penciclovir1% · cream;topical | Penciclovir | 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
