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Treats herpes zoster (shingles). ANDA 75677, held by Apotex. Acyclovir.
As of Nov 13, 2026, ANDA 75677 (Acyclovir), held by Apotex, was first approved by FDA on Sep 28, 2005, with 2 approved supplements and 0 published complete response letters.
First approved: Sep 28, 2005
Supplements approved: 2
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
INDICATIONS AND USAGE Herpes Zoster Infections Acyclovir capsule is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes Acyclovir capsule is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox Acyclovir capsule is 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