Acyclovir

ANDA 74727, held by Aurobindo Pharma USA. Acyclovir.

As of Nov 13, 2026, ANDA 74727 (Acyclovir), held by Aurobindo Pharma USA, was first approved by FDA on Apr 22, 1997, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 22, 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
Apr 22, 1997	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acyclovir200MG · capsule;oral	Acyclovir	Discontinued

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 7, 2009	Supplement 12Labeling	Approved	None posted
Oct 21, 2004	Supplement 8Labeling	Approved	None posted
Jul 31, 2002	Supplement 6Labeling	Approved	None posted
Mar 13, 2002	Supplement 5Labeling	Approved	None posted
Nov 30, 2000	Supplement 4Manufacturing	Approved	None posted
Aug 5, 1999	Supplement 3Manufacturing	Approved	None posted
Jun 8, 1998	Supplement 1Manufacturing	Approved	None posted
Mar 31, 1998	Supplement 2Labeling	Approved	None posted
Apr 22, 1997	Original application	Approved	Review

Identifiers

Application: ANDA 74727
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma USA

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