Valacyclovir Hydrochloride

Reduces transmission. ANDA 79012, held by Rising. Valacyclovir Hydrochloride.

As of Nov 15, 2026, ANDA 79012 (Valacyclovir Hydrochloride), held by Rising, was first approved by FDA on May 24, 2010, with 3 approved supplements and 0 published complete response letters.

First approved: May 24, 2010
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Valacyclovir 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 have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1-infected patients. 1.1 Adult Patients Cold Sores (Herpes Labialis) Valacyclovir is indicated for treatment of cold sores (herpes labialis).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 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 4 submissions, including labeling and manufacturing supplements


Mar 28, 2023	Supplement 7Labeling · Standard review	Approved	None posted
Mar 20, 2013	Supplement 5Labeling · Standard review	Approved	None posted
Jan 17, 2013	Supplement 4Labeling · Standard review	Approved	None posted
May 24, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 79012
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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