Valacyclovir Hydrochloride

ANDA 77478, held by Aiping Pharm Inc. Valacyclovir Hydrochloride.

As of Nov 15, 2026, ANDA 77478 (Valacyclovir Hydrochloride), held by Aiping Pharm Inc, 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

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	Discontinued
Valacyclovir HydrochlorideEQ 1GM BASE · tablet;oral	Valacyclovir Hydrochloride	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Mar 31, 2023	Supplement 14Labeling · Standard review	Approved	None posted
Oct 26, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Feb 1, 2013	Supplement 8Labeling · Standard review	Approved	None posted
May 24, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 77478
Drugs@FDA: Overview at FDA
Company: Aiping Pharmaceutical

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