Valacyclovir Hydrochloride

Reduces transmission Herpes Zoster Pediatric Patients Cold Sores (Herpes Labialis)…. ANDA 201506, held by Jubilant Generics. Valacyclovir Hydrochloride.

As of Nov 15, 2026, ANDA 201506 (Valacyclovir Hydrochloride), held by Jubilant Generics, was first approved by FDA on Apr 3, 2012, with 6 approved supplements and 0 published complete response letters.

First approved: Apr 3, 2012
Supplements approved: 6
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-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 7 submissions below

Date	Submission	Status	Documents
Apr 3, 2012	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 7 submissions, including labeling and manufacturing supplements


Jan 30, 2026	Supplement 26Labeling · Standard review	Approved	None posted
Jan 30, 2026	Supplement 25Labeling · Standard review	Approved	None posted
Jan 30, 2026	Supplement 24Labeling · Standard review	Approved	None posted
Apr 17, 2023	Supplement 22Labeling · Standard review	Approved	None posted
Apr 17, 2023	Supplement 17Labeling · Standard review	Approved	None posted
Oct 30, 2012	Supplement 1Labeling · Standard review	Approved	None posted
Apr 3, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 201506
Drugs@FDA: Overview at FDA
Company: Jubilant Generics

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