Valacyclovir Hydrochloride

Reduces transmission Herpes Zoster Pediatric Patients Cold Sores (Herpes Labialis)…. ANDA 76588, held by Sun Pharm Inds Ltd. Valacyclovir Hydrochloride.

As of Nov 15, 2026, ANDA 76588 (Valacyclovir Hydrochloride), held by Sun Pharm Inds Ltd, was first approved by FDA on Jan 31, 2007, with 9 approved supplements and 0 published complete response letters.

First approved: Jan 31, 2007
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Valacyclovir tablets are 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 10 submissions below

Date	Submission	Status	Documents
Jan 31, 2007	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 10 submissions, including labeling and manufacturing supplements


Mar 23, 2023	Supplement 29Labeling · Standard review	Approved	None posted
Mar 23, 2023	Supplement 32Labeling · Standard review	Approved	None posted
Mar 23, 2023	Supplement 34Labeling · Standard review	Approved	None posted
Feb 28, 2020	Supplement 21Labeling · Standard review	Approved	None posted
Feb 16, 2018	Supplement 16Manufacturing	Approved	None posted
May 14, 2013	Supplement 19Labeling · Standard review	Approved	None posted
Jul 20, 2010	Supplement 6Labeling	Approved	None posted
Jul 20, 2010	Supplement 12Labeling	Approved	None posted
Jul 20, 2010	Supplement 13Labeling	Approved	None posted
Jan 31, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 76588
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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