Acyclovir Sodium

ANDA 206606, held by Zydus Pharms. Acyclovir Sodium.

As of Nov 14, 2026, ANDA 206606 (Acyclovir Sodium), held by Zydus Pharms, was first approved by FDA on Jun 13, 2017, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 13, 2017
Review: Standard
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
Jun 13, 2017	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


Feb 18, 2025	Supplement 1Labeling · Standard review	Approved	None posted
Jun 13, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 206606
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

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