Treats herpes zoster (shingles). ANDA 203834, held by Hetero Labs Ltd V. Acyclovir.
As of Nov 13, 2026, ANDA 203834 (Acyclovir), held by Hetero Labs Ltd V, was first approved by FDA on Oct 29, 2013, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Herpes Zoster Infections: Acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 29, 2013 | 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
