← FDA DRUG APPROVALS

FDA NDA · NDA020487

VALTREX

valacyclovir hydrochloride

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA020487
TYPE
NDA
ORIGINAL APPROVAL
1995-06-23
LATEST ACTION
2025-11-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VALTREX · ReferencePrescription
VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE · TABLET · ORAL
VALTREX · ReferencePrescription
VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE · TABLET · ORAL

Approval history

2025-11-12Labeling · Supplement 23 · standard — Label ↗AP
2021-06-14Labeling · Supplement 22 · standard — Letter ↗AP
2019-12-10Labeling · Supplement 20 · standard — Letter ↗AP
2010-04-19Labeling · Supplement 16 · unknown — Letter ↗AP
2008-09-02Efficacy · Supplement 14 · priority — Letter ↗AP
2007-12-11Labeling · Supplement 13 · standard — Label ↗AP
2005-11-23Labeling · Supplement 7 · standard — Label ↗AP
2004-12-03Labeling · Supplement 5 · standard — Review ↗AP
1997-01-13Labeling · Supplement 4 · standard — Review ↗AP
1996-08-09Manufacturing (CMC) · Supplement 3 · standard — Review ↗AP
1995-09-08Manufacturing (CMC) · Supplement 2 · standard — Review ↗AP
1995-06-23Type 2 - New Active Ingredient · Original · standard — Pediatric Medical Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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