ANDA 213951, held by Vistapharm LLC. Acyclovir.
As of Nov 13, 2026, ANDA 213951 (Acyclovir), held by Vistapharm LLC, was first approved by FDA on Jan 11, 2021, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 11, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acyclovir200MG/5ML · suspension;oral | Acyclovir | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 1, 2026 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jan 11, 2021 | Original application | Approved | None posted |
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
