Treats recurrent herpes labialis (cold sores). ANDA 212368, held by Padagis Israel. Penciclovir.
As of Nov 14, 2026, ANDA 212368 (Penciclovir), held by Padagis Israel, was first approved by FDA on Sep 27, 2024, 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 |
|---|---|---|---|
| Sep 27, 2024 | 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
