Acyclovir Sodium

ANDA 74913, held by Eurohlth Intl Sarl. Acyclovir Sodium.

As of Nov 14, 2026, ANDA 74913 (Acyclovir Sodium), held by Eurohlth Intl Sarl, was first approved by FDA on Oct 15, 1997, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 15, 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
Oct 15, 1997	Original application	Approved	None posted

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Jul 17, 2000	Supplement 1Labeling	Approved	None posted
Oct 15, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74913
Drugs@FDA: Overview at FDA
Company: Eurohlth Intl Sarl

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