Valacyclovir Hydrochloride

Reduces transmission Herpes Zoster Pediatric Patients Cold Sores (Herpes Labialis)…. ANDA 90682, held by Aurobindo Pharma. Valacyclovir Hydrochloride.

As of Nov 15, 2026, ANDA 90682 (Valacyclovir Hydrochloride), held by Aurobindo Pharma, was first approved by FDA on May 24, 2010, with 7 approved supplements and 0 published complete response letters.

First approved: May 24, 2010
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients Cold Sores (Herpes Labialis) Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-1-infected patients Reduction of transmission Herpes Zoster Pediatric Patients Cold Sores (Herpes Labialis) Chickenpox Limitations of Use The efficacy and safety of valacyclovir tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1-infected patients. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 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	Rx
Valacyclovir HydrochlorideEQ 1GM BASE · tablet;oral	Valacyclovir Hydrochloride	Rx

All 8 submissions, including labeling and manufacturing supplements


Sep 21, 2026	Supplement 27Labeling · Standard review	Approved	None posted
May 8, 2023	Supplement 20Labeling · Standard review	Approved	None posted
May 8, 2023	Supplement 17Labeling · Standard review	Approved	None posted
Aug 13, 2015	Supplement 7Labeling	Approved	None posted
Jan 27, 2015	Supplement 9Manufacturing	Approved	None posted
Oct 24, 2014	Supplement 8Manufacturing	Approved	None posted
Mar 15, 2013	Supplement 6Manufacturing	Approved	None posted
May 24, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90682
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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