Acyclovir

Treats herpes zoster (shingles). ANDA 202168, held by Cadila Pharms Ltd. Acyclovir.

As of Nov 13, 2026, ANDA 202168 (Acyclovir), held by Cadila Pharms Ltd, was first approved by FDA on Nov 15, 2013, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 15, 2013
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS & USAGE Herpes Zoster Infections: Acyclovir Tablet is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir Tablet is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox:Acyclovir Tablet is indicated for the treatment of chickenpox (varicella).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Nov 15, 2013	Original application	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Acyclovir400MG · tablet;oral	Acyclovir	Rx
Acyclovir800MG · tablet;oral	Acyclovir	Rx

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 3, 2026	Supplement 4Labeling · Standard review	Approved	None posted
Dec 23, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Nov 15, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 202168
Drugs@FDA: Overview at FDA
Company: Cadila Pharmaceuticals

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