Acyclovir Sodium

ANDA 74596, held by Chartwell Injectable. Acyclovir Sodium.

As of Nov 14, 2026, ANDA 74596 (Acyclovir Sodium), held by Chartwell Injectable, was first approved by FDA on Apr 22, 1997, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 22, 1997
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

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

Products

2 strengths and forms


Acyclovir SodiumEQ 1GM BASE/VIAL · injectable;injection	Acyclovir Sodium	Discontinued
Acyclovir SodiumEQ 500MG BASE/VIAL · injectable;injection	Acyclovir Sodium	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Sep 13, 2000	Supplement 1Labeling	Approved	None posted
Apr 22, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74596
Drugs@FDA: Overview at FDA
Company: Chartwell Injectable

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