Treats herpes zoster (shingles). ANDA 204314, held by Zydus Pharms. Acyclovir.
As of Nov 13, 2026, ANDA 204314 (Acyclovir), held by Zydus Pharms, was first approved by FDA on Aug 19, 2014, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Herpes Zoster Infections: Acyclovir tablets are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets are indicated for the treatment of chickenpox (varicella).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 19, 2014 | 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
