Valacyclovir Hydrochloride

ANDA 79137, held by Zydus Lifesciences. Valacyclovir Hydrochloride.

As of Nov 15, 2026, ANDA 79137 (Valacyclovir Hydrochloride), held by Zydus Lifesciences, was first approved by FDA on Dec 29, 2017, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 29, 2017
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
Dec 29, 2017	Original application	Approved	None posted

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Mar 14, 2025	Supplement 1Labeling · Standard review	Approved	None posted
Dec 29, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 79137
Drugs@FDA: Overview at FDA
Company: Zydus Lifesciences

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