Zovirax

NDA 19909, held by Pharmobedient. Acyclovir.

As of Nov 13, 2026, NDA 19909 (Zovirax), held by Pharmobedient, was first approved by FDA on Dec 22, 1989, with 20 approved supplements and 0 published complete response letters.

First approved: Dec 22, 1989
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Feb 26, 1992	Supplement 3Efficacy (new indication or use)	Approved	Review
Dec 22, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Zovirax200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · suspension;oral	Acyclovir	DiscontinuedReference drug

All 21 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 12, 2025	Supplement 28Labeling · Standard review	Approved	Label Letter
Apr 18, 2016	Supplement 23Manufacturing · Standard review	Approved	None posted
Aug 8, 2008	Supplement 22Labeling · Standard review	Approved	Letter
Dec 9, 2005	Supplement 20Labeling · Standard review	Approved	Letter Label
May 19, 2004	Supplement 19Labeling · Standard review	Approved	Label Letter
Nov 14, 2001	Supplement 17Labeling · Standard review	Approved	Label
Nov 14, 2001	Supplement 16Labeling · Standard review	Approved	Label
Jul 12, 2000	Supplement 15Manufacturing · Standard review	Approved	None posted
Mar 15, 2000	Supplement 14Labeling · Standard review	Approved	None posted
Feb 25, 1998	Supplement 13Manufacturing · Standard review	Approved	None posted
May 29, 1997	Supplement 12Labeling · Standard review	Approved	None posted
Jan 8, 1997	Supplement 11Labeling · Standard review	Approved	None posted
Oct 29, 1996	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 12, 1995	Supplement 8Labeling · Standard review	Approved	None posted
Apr 14, 1994	Supplement 6Labeling · Standard review	Approved	None posted
Nov 9, 1993	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 22, 1993	Supplement 4Labeling	Approved	None posted
Feb 26, 1992	Supplement 3Efficacy (new indication or use)	Approved	Review
Apr 30, 1991	Supplement 2Labeling	Approved	None posted
Apr 26, 1990	Supplement 1Labeling	Approved	None posted
Dec 22, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19909
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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