Treats herpes zoster (shingles). ANDA 210401, held by Pharmobedient. Acyclovir.
As of Nov 14, 2026, ANDA 210401 (Acyclovir), held by Pharmobedient, was first approved by FDA on Mar 7, 2018, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Herpes Zoster Infections: Acyclovir tablets is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets is indicated for the treatment of chickenpox (varicella).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 7, 2018 | Original application | Approved | None posted |
| Jun 24, 2026 | Supplement 5Labeling · Standard review | Approved | None posted |
| Mar 7, 2018 | 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
