Acyclovir

Treats herpes zoster (shingles). ANDA 75382, held by Carlsbad. Acyclovir.

As of Nov 14, 2026, ANDA 75382 (Acyclovir), held by Carlsbad, was first approved by FDA on Apr 30, 1999, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 30, 1999
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Herpes Zoster Infections Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox Acyclovir 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 5 submissions below

Date	Submission	Status	Documents
Apr 30, 1999	Original application	Approved	Review Letter

Products

2 strengths and forms


Acyclovir400MG · tablet;oral	Acyclovir	Rx
Acyclovir800MG · tablet;oral	Acyclovir	Rx

All 5 submissions, including labeling and manufacturing supplements


Sep 16, 2005	Supplement 6Labeling	Approved	None posted
Apr 25, 2003	Supplement 3Labeling	Approved	None posted
Sep 19, 2002	Supplement 2Manufacturing	Approved	None posted
Nov 16, 2000	Supplement 1Labeling	Approved	None posted
Apr 30, 1999	Original application	Approved	Review Letter

Identifiers

Application: ANDA 75382
Drugs@FDA: Overview at FDA
Company: Carlsbad Technology

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