ANDA 212495, held by Chartwell Rx. Acyclovir.
As of Nov 13, 2026, ANDA 212495 (Acyclovir), held by Chartwell Rx, was first approved by FDA on Apr 7, 2020, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 7, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acyclovir5% ยท ointment;topical | Acyclovir | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
