Acyclovir

ANDA 74836, held by Ivax Sub Teva Pharms. Acyclovir.

As of Nov 13, 2026, ANDA 74836 (Acyclovir), held by Ivax Sub Teva Pharms, was first approved by FDA on Apr 22, 1997, with 19 approved supplements and 0 published complete response letters.

First approved: Apr 22, 1997
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Apr 22, 1997	Original application	Approved	None posted

Products

2 strengths and forms

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

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 17, 2006	Supplement 28Labeling	Approved	None posted
Mar 14, 2005	Supplement 26Labeling	Approved	None posted
Nov 5, 2002	Supplement 17Manufacturing	Approved	None posted
Jul 29, 2002	Supplement 18Manufacturing	Approved	None posted
Mar 12, 2002	Supplement 16Manufacturing	Approved	None posted
Sep 12, 2001	Supplement 15Manufacturing	Approved	None posted
Jan 4, 2001	Supplement 14Labeling	Approved	None posted
Dec 21, 2000	Supplement 12Manufacturing	Approved	None posted
Jun 7, 2000	Supplement 10Manufacturing	Approved	None posted
Jun 7, 2000	Supplement 13Labeling	Approved	None posted
Jan 28, 2000	Supplement 11Manufacturing	Approved	None posted
Jun 15, 1999	Supplement 4Manufacturing	Approved	None posted
Jun 15, 1999	Supplement 6Manufacturing	Approved	None posted
Jun 15, 1999	Supplement 7Manufacturing	Approved	None posted
Jun 15, 1999	Supplement 8Manufacturing	Approved	None posted
Feb 9, 1999	Supplement 2Manufacturing	Approved	None posted
Jan 8, 1999	Supplement 9Labeling	Approved	None posted
Dec 9, 1998	Supplement 3Manufacturing	Approved	None posted
Feb 25, 1998	Supplement 1Manufacturing	Approved	None posted
Apr 22, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74836
Drugs@FDA: Overview at FDA
Company: IVAX Pharmaceuticals

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