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FDA NDA · NDA020550

VALTREX

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA020550
TYPE
NDA
ORIGINAL APPROVAL
1995-12-15
LATEST ACTION
2003-08-29
ROUTE
Oral, ORAL
DOSAGE FORM
Tablet, TABLET
MARKETING STATUS
Prescription

Products

VALTREXPrescription
VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE · Tablet · Oral
VALTREXPrescription
VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE · TABLET · ORAL

Approval history

2003-08-29Efficacy · Supplement 19 · standard — Letter ↗AP
2003-08-08Labeling · Supplement 21 · standard — Letter ↗AP
2003-04-01Efficacy · Supplement 5 · standard — Label ↗AP
2002-12-18Manufacturing (CMC) · Supplement 18 · priorityAP
2002-09-09Efficacy · Supplement 16 · standard — Letter ↗AP
2002-07-03Manufacturing (CMC) · Supplement 17 · priorityAP
2002-03-14Manufacturing (CMC) · Supplement 15 · priorityAP
2001-06-25Labeling · Supplement 13 · standard — Label ↗AP
2001-06-25Efficacy · Supplement 12 · standard — Label ↗AP
2001-06-25Labeling · Supplement 10 · standard — Label ↗AP
2001-06-01Manufacturing (CMC) · Supplement 14 · priorityAP
2000-04-20Labeling · Supplement 11 · standardAP
2000-04-20Labeling · Supplement 9 · standardAP
1999-07-22Manufacturing (CMC) · Supplement 8 · priorityAP
1999-02-02Manufacturing (CMC) · Supplement 7 · priorityAP
1998-11-25Manufacturing (CMC) · Supplement 6 · priorityAP
1997-09-26Efficacy · Supplement 3 · standard — Review ↗AP
1997-04-30Labeling · Supplement 4 · standardAP
1996-10-18Labeling · Supplement 2 · standardAP
1996-10-04Efficacy · Supplement 1 · priorityAP
1995-12-15Type 6 - New Indication (no longer used) · Original · priorityAP
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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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