Valacyclovir Hydrochloride

ANDA 90370, held by Watson Labs Inc. Valacyclovir Hydrochloride.

As of Nov 15, 2026, ANDA 90370 (Valacyclovir Hydrochloride), held by Watson Labs Inc, was first approved by FDA on Mar 16, 2011, with 1 approved supplement and 0 published complete response letters.

First approved: Mar 16, 2011
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Mar 16, 2011	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 2 submissions, including labeling and manufacturing supplements


Mar 12, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Mar 16, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90370
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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