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Treats herpes zoster (shingles). ANDA 204313, held by Cadila. Acyclovir.
As of Nov 13, 2026, ANDA 204313 (Acyclovir), held by Cadila, was first approved by FDA on Mar 25, 2016, with 1 approved supplement and 0 published complete response letters.
First approved: Mar 25, 2016
Supplements approved: 1
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
INDICATIONS AND USAGE Herpes Zoster Infections: Acyclovir capsules are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir capsules are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir capsules are indicated for the treatment of chickenpox (varicella).
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
