Treats recurrent herpes labialis (cold sores). ANDA 212710, held by Teva Pharms USA. Penciclovir.
As of Nov 14, 2026, ANDA 212710 (Penciclovir), held by Teva Pharms USA, was first approved by FDA on Nov 9, 2022, 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 |
|---|---|---|---|
| Nov 9, 2022 | Original application | Approved |
| 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
