Zovirax

NDA 18603, held by Glaxosmithkline. Acyclovir Sodium.

As of Nov 13, 2026, NDA 18603 (Zovirax), held by Glaxosmithkline, was first approved by FDA on Oct 22, 1982, with 26 approved supplements and 0 published complete response letters.

First approved: Oct 22, 1982
Review: Priority
Supplements approved: 26
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below


Jun 2, 1998	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 9, 1990	Supplement 9Efficacy (new indication or use)	Approved	None posted
Feb 9, 1990	Supplement 3Efficacy (new indication or use)	Approved	None posted
Oct 22, 1982	Original applicationTYPE 2/3 · Priority review	Approved	None posted

Products

3 strengths and forms


ZoviraxEQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Acyclovir Sodium	DiscontinuedReference drug
ZoviraxEQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Acyclovir Sodium	DiscontinuedReference drug
ZoviraxEQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Acyclovir Sodium	DiscontinuedReference drug

All 27 submissions, including labeling and manufacturing supplements


Jan 25, 2019	Supplement 30Labeling · Standard review	Approved	Letter Label
May 19, 2004	Supplement 27Labeling · Standard review	Approved	Letter Label
Jan 29, 2002	Supplement 25Labeling · Standard review	Approved	Letter
Jan 29, 2002	Supplement 24Labeling · Standard review	Approved	Letter
Jan 29, 2002	Supplement 23Labeling · Standard review	Approved	Letter
Jul 12, 2000	Supplement 22Manufacturing · Priority review	Approved	None posted
Jul 15, 1999	Supplement 21Manufacturing · Priority review	Approved	None posted
May 19, 1999	Supplement 20Labeling · Standard review	Approved	None posted
Jun 2, 1998	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 29, 1996	Supplement 18Manufacturing · Priority review	Approved	None posted
Jun 7, 1995	Supplement 17Manufacturing · Priority review	Approved	None posted
Apr 14, 1994	Supplement 15Labeling · Standard review	Approved	None posted
Nov 9, 1993	Supplement 14Manufacturing · Priority review	Approved	None posted
Apr 22, 1993	Supplement 13Labeling	Approved	None posted
Apr 22, 1993	Supplement 10Labeling	Approved	None posted
Jul 17, 1992	Supplement 12Manufacturing · Priority review	Approved	None posted
Feb 9, 1990	Supplement 9Efficacy (new indication or use)	Approved	None posted
Feb 9, 1990	Supplement 3Efficacy (new indication or use)	Approved	None posted
Jun 29, 1989	Supplement 11Manufacturing · Priority review	Approved	None posted
Aug 14, 1984	Supplement 6Manufacturing · Priority review	Approved	None posted
Jul 9, 1984	Supplement 8Labeling	Approved	None posted
May 31, 1984	Supplement 7Manufacturing · Priority review	Approved	None posted
May 8, 1984	Supplement 5Manufacturing · Priority review	Approved	None posted
Aug 30, 1983	Supplement 4Manufacturing · Priority review	Approved	None posted
Jan 5, 1983	Supplement 2Manufacturing · Priority review	Approved	None posted
Dec 14, 1982	Supplement 1Manufacturing · Priority review	Approved	None posted
Oct 22, 1982	Original applicationTYPE 2/3 · Priority review	Approved	None posted

Identifiers

Application: NDA 18603
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

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