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FDA NDA · NDA020705

RESCRIPTOR

Sponsor: VIIV HLTHCARE

APPLICATION
NDA020705
TYPE
NDA
ORIGINAL APPROVAL
1997-04-04
LATEST ACTION
2012-08-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

RESCRIPTOR · ReferenceDiscontinued
DELAVIRDINE MESYLATE 100MG · TABLET · ORAL
RESCRIPTOR · ReferenceDiscontinued
DELAVIRDINE MESYLATE 200MG · TABLET · ORAL

Approval history

2012-08-10Labeling · Supplement 18 · 901 required — Label ↗AP
2006-04-07Labeling · Supplement 10 · standard — Letter ↗AP
2002-03-14Labeling · Supplement 9 · standard — Review ↗AP
2001-05-16Efficacy · Supplement 8 · standard — Review ↗AP
1999-08-16Labeling · Supplement 4 · standard — Review ↗AP
1999-07-14Manufacturing (CMC) · Supplement 3 · priority — Review ↗AP
1998-10-23Manufacturing (CMC) · Supplement 2 · priority — Review ↗AP
1998-02-11Labeling · Supplement 1 · standardAP
1997-04-04Type 1 - New Molecular Entity · Original · priorityAP
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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