Acyclovir

ANDA 74870, held by Actavis Elizabeth. Acyclovir.

As of Nov 13, 2026, ANDA 74870 (Acyclovir), held by Actavis Elizabeth, was first approved by FDA on Jun 5, 1997, with 6 approved supplements and 0 published complete response letters.

First approved: Jun 5, 1997
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jun 5, 1997	Original application	Approved	Review

Products

2 strengths and forms

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

All 7 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 28, 2004	Supplement 9Labeling	Approved	None posted
Apr 23, 2002	Supplement 5Labeling	Approved	None posted
Nov 2, 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
Jun 5, 1997	Original application	Approved	Review

Identifiers

Application: ANDA 74870
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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