Acyclovir

ANDA 74906, held by Actavis Elizabeth. Acyclovir.

As of Nov 14, 2026, ANDA 74906 (Acyclovir), held by Actavis Elizabeth, was first approved by FDA on Aug 26, 1997, with 8 approved supplements and 0 published complete response letters.

First approved: Aug 26, 1997
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Aug 26, 1997	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acyclovir200MG · capsule;oral	Acyclovir	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Oct 28, 2004	Supplement 14Labeling	Approved	None posted
Apr 23, 2002	Supplement 7Labeling	Approved	None posted
Nov 2, 2001	Supplement 6Manufacturing	Approved	None posted
May 1, 2001	Supplement 5Manufacturing	Approved	None posted
Mar 8, 2001	Supplement 4Manufacturing	Approved	None posted
Jul 17, 2000	Supplement 3Labeling	Approved	None posted
Aug 10, 1998	Supplement 2Labeling	Approved	None posted
Mar 26, 1998	Supplement 1Labeling	Approved	None posted
Aug 26, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74906
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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