Treats herpes zoster (shingles). ANDA 212718, held by Chartwell Rx. Acyclovir.
As of Nov 13, 2026, ANDA 212718 (Acyclovir), held by Chartwell Rx, was first approved by FDA on Apr 23, 2020, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Herpes Zoster Infections: Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir is indicated for the treatment of chickenpox (varicella).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 23, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acyclovir200MG/5ML · suspension;oral | Acyclovir | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 1, 2026 | Supplement 3Labeling · Standard review | Approved | None posted |
| Apr 23, 2020 | 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
