Valacyclovir Hydrochloride

Reduces transmission. ANDA 203047, held by Hetero Labs Ltd V. Valacyclovir Hydrochloride.

As of Nov 15, 2026, ANDA 203047 (Valacyclovir Hydrochloride), held by Hetero Labs Ltd V, was first approved by FDA on Apr 8, 2015, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 8, 2015
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Valacyclovir tablet 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 5 submissions below

Date	Submission	Status	Documents
Apr 8, 2015	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 5 submissions, including labeling and manufacturing supplements


Jun 10, 2026	Supplement 20Labeling · Standard review	Approved	None posted
Feb 23, 2023	Supplement 12Labeling · Standard review	Approved	None posted
Feb 23, 2023	Supplement 14Labeling · Standard review	Approved	None posted
Oct 26, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Apr 8, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 203047
Drugs@FDA: Overview at FDA
Company: Hetero Labs Ltd

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