ANDA 216981, held by Torrent. Penciclovir.
As of Nov 14, 2026, ANDA 216981 (Penciclovir), held by Torrent, was first approved by FDA on Aug 7, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 7, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Penciclovir1% ยท cream;topical | Penciclovir | Discontinued |
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
