Acyclovir Sodium

ANDA 74720, held by Hospira. Acyclovir Sodium.

As of Nov 14, 2026, ANDA 74720 (Acyclovir Sodium), held by Hospira, was first approved by FDA on Apr 22, 1997, with 12 approved supplements and 0 published complete response letters.

First approved: Apr 22, 1997
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

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

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acyclovir SodiumEQ 25MG BASE/ML · injectable;injection	Acyclovir Sodium	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Sep 30, 2004	Supplement 19Labeling	Approved	None posted
Oct 10, 2003	Supplement 17Labeling	Approved	None posted
Nov 27, 2000	Supplement 14Labeling	Approved	None posted
Sep 29, 2000	Supplement 9Manufacturing	Approved	None posted
Aug 21, 2000	Supplement 10Labeling	Approved	None posted
Aug 8, 2000	Supplement 8Manufacturing	Approved	None posted
Apr 28, 2000	Supplement 7Manufacturing	Approved	None posted
Jun 18, 1999	Supplement 6Manufacturing	Approved	None posted
Sep 25, 1998	Supplement 5Manufacturing	Approved	None posted
Sep 25, 1998	Supplement 3Manufacturing	Approved	None posted
Jun 22, 1998	Supplement 4Manufacturing	Approved	None posted
Jun 27, 1997	Supplement 1Labeling	Approved	None posted
Apr 22, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74720
Drugs@FDA: Overview at FDA
Company: Hospira

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