← FDA DRUG APPROVALS

FDA NDA · NDA022187

ETRAVIRINE

Sponsor: JANSSEN R AND D

APPLICATION
NDA022187
TYPE
NDA
ORIGINAL APPROVAL
2008-01-18
LATEST ACTION
2019-07-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

INTELENCE · ReferencePrescription
ETRAVIRINE 200MG · TABLET · ORAL
INTELENCE · ReferencePrescription
ETRAVIRINE 25MG · TABLET · ORAL
INTELENCE · ReferencePrescription
ETRAVIRINE 100MG · TABLET · ORAL

Approval history

2019-07-10Labeling · Supplement 25 · standard — Letter ↗AP
2018-11-06Efficacy · Supplement 23 · standard — Label ↗AP
2018-07-16Efficacy · Supplement 24 · priority — Label ↗AP
2016-05-20Manufacturing (CMC) · Supplement 19 · priorityAP
2016-03-10Manufacturing (CMC) · Supplement 18 · priorityAP
2015-05-06Manufacturing (CMC) · Supplement 17 · priorityAP
2014-08-20Labeling · Supplement 16 · standard — Letter ↗AP
2013-07-08Manufacturing (CMC) · Supplement 15 · priorityAP
2013-04-30Manufacturing (CMC) · Supplement 13 · priorityAP
2013-02-27Labeling · Supplement 11 · standard — Letter ↗AP
2013-02-27Labeling · Supplement 14 · standard — Label ↗AP
2013-02-27Labeling · Supplement 12 · standard — Label ↗AP
2012-08-10Labeling · Supplement 10 · 901 required — Label ↗AP
2012-03-26Efficacy · Supplement 9 · priority — Letter ↗AP
2011-10-07Labeling · Supplement 8 · unknown — Letter ↗AP
2010-12-22Manufacturing (CMC) · Supplement 7 — Label ↗AP
2010-12-17Labeling · Supplement 6 · standard — Label ↗AP
2010-02-23Labeling · Supplement 3 · unknown — Label ↗AP
2009-11-24Efficacy · Supplement 1 · standard — Label ↗AP
2009-09-15Labeling · Supplement 2 · unknown — Label ↗AP
2008-01-18Type 1 - New Molecular Entity · Original · priority — Label ↗AP
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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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