Valacyclovir Hydrochloride

ANDA 90500, held by Apotex. Valacyclovir Hydrochloride.

As of Nov 15, 2026, ANDA 90500 (Valacyclovir Hydrochloride), held by Apotex, was first approved by FDA on Apr 4, 2014, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 4, 2014
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Apr 4, 2014	Original application	Approved	None posted

Products

2 strengths and forms


Valacyclovir HydrochlorideEQ 500MG BASE · tablet;oral	Valacyclovir Hydrochloride	Discontinued
Valacyclovir HydrochlorideEQ 1GM BASE · tablet;oral	Valacyclovir Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Feb 7, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Mar 23, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Apr 4, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 90500
Drugs@FDA: Overview at FDA
Company: Apotex

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