Valacyclovir Hydrochloride

ANDA 78656, held by Hikma. Valacyclovir Hydrochloride.

As of Nov 15, 2026, ANDA 78656 (Valacyclovir Hydrochloride), held by Hikma, was first approved by FDA on May 24, 2010, with 2 approved supplements and 0 published complete response letters.

First approved: May 24, 2010
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
May 24, 2010	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


Nov 19, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Sep 10, 2020	Supplement 3Labeling · Standard review	Approved	None posted
May 24, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 78656
Drugs@FDA: Overview at FDA
Company: Hikma

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