Treats herpes zoster (shingles). ANDA 216331, held by Aurobindo Pharma. Acyclovir.
As of Nov 14, 2026, ANDA 216331 (Acyclovir), held by Aurobindo Pharma, was first approved by FDA on Mar 31, 2022, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Herpes Zoster Infections: Acyclovir oral suspension is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir oral suspension is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir oral suspension is indicated for the treatment of chickenpox (varicella).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 31, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acyclovir200MG/5ML · suspension;oral | Acyclovir | Rx |
| Jul 1, 2026 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 31, 2022 | Original application | Approved | None posted |
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
