Acyclovir Sodium

ANDA 75015, held by Fresenius Kabi USA. Acyclovir Sodium.

As of Nov 14, 2026, ANDA 75015 (Acyclovir Sodium), held by Fresenius Kabi USA, was first approved by FDA on Apr 30, 1998, with 3 approved supplements and 0 published complete response letters.

First approved: Apr 30, 1998
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Apr 30, 1998	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acyclovir SodiumEQ 500MG BASE/VIAL · injectable;injection	Acyclovir Sodium	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Dec 5, 2002	Supplement 4Manufacturing	Approved	None posted
Jul 9, 2002	Supplement 3Labeling	Approved	None posted
Aug 21, 2000	Supplement 1Labeling	Approved	None posted
Apr 30, 1998	Original application	Approved	None posted

Identifiers

Application: ANDA 75015
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi 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