Acyclovir In Sodium Chloride 0.9% Preservative Free

ANDA 74885, held by Eurohlth Intl Sarl. Acyclovir Sodium.

As of Nov 14, 2026, ANDA 74885 (Acyclovir In Sodium Chloride 0.9% Preservative Free), held by Eurohlth Intl Sarl, was first approved by FDA on Dec 19, 1997, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 19, 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
Dec 19, 1997	Original application	Approved	None posted

Products

2 strengths and forms


Acyclovir In Sodium Chloride 0.9% Preservative FreeEQ 500MG BASE/VIAL · injectable;injection	Acyclovir Sodium	Discontinued
Acyclovir In Sodium Chloride 0.9% Preservative FreeEQ 1GM BASE/VIAL · injectable;injection	Acyclovir Sodium	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Apr 19, 2000	Supplement 1Labeling	Approved	None posted
Dec 19, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74885
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