ANDA 205591, held by Cosette Pharms Nc. Acyclovir.
As of Nov 13, 2026, ANDA 205591 (Acyclovir), held by Cosette Pharms Nc, was first approved by FDA on Nov 13, 2017, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 13, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acyclovir5% ยท ointment;topical | Acyclovir | Discontinued |
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
