Treats herpes zoster (shingles). ANDA 201445, held by Cadila Pharms Ltd. Acyclovir.
As of Nov 14, 2026, ANDA 201445 (Acyclovir), held by Cadila Pharms Ltd, was first approved by FDA on Mar 6, 2014, with 0 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE Herpes Zoster Infections: Acyclovir capsules is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir capsules is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir capsules is indicated for the treatment of chickenpox (varicella).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 6, 2014 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acyclovir200MG · capsule;oral | Acyclovir | Rx |
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
