Acyclovir Sodium

ANDA 74969, held by Teva Parenteral. Acyclovir Sodium.

As of Nov 14, 2026, ANDA 74969 (Acyclovir Sodium), held by Teva Parenteral, was first approved by FDA on Aug 26, 1997, with 4 approved supplements and 0 published complete response letters.

First approved: Aug 26, 1997
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Aug 26, 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 5 submissions, including labeling and manufacturing supplements


Jul 9, 2002	Supplement 4Labeling	Approved	None posted
Feb 1, 2002	Supplement 3Labeling	Approved	None posted
Jun 9, 2000	Supplement 2Labeling	Approved	None posted
Mar 22, 1999	Supplement 1Manufacturing	Approved	None posted
Aug 26, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74969
Drugs@FDA: Overview at FDA
Company: Teva Parenteral Medicines

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