← FDA DRUG APPROVALS

FDA NDA · NDA022145

ISENTRESS

raltegravir

Sponsor: MSD SUB MERCK

APPLICATION
NDA022145
TYPE
NDA
ORIGINAL APPROVAL
2007-10-12
LATEST ACTION
2021-05-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ISENTRESS HD · ReferencePrescription
RALTEGRAVIR POTASSIUM EQ 600MG BASE · TABLET · ORAL
ISENTRESS · ReferencePrescription
RALTEGRAVIR POTASSIUM EQ 400MG BASE · TABLET · ORAL

Approval history

2021-05-18Labeling · Supplement 44 · standard — Letter ↗AP
2020-07-14Efficacy · Supplement 42 · standard — Label ↗AP
2018-06-15Labeling · Supplement 39 · standard — Letter ↗AP
2018-03-05Efficacy · Supplement 38 · standard — Label ↗AP
2017-11-22Efficacy · Supplement 37 · priority — Label ↗AP
2017-05-26Efficacy · Supplement 36 · standard — Label ↗AP
2015-02-20Labeling · Supplement 35 · standard — Label ↗AP
2015-02-18Labeling · Supplement 34 · standard — Letter ↗AP
2014-10-10Manufacturing (CMC) · Supplement 33 · priorityAP
2014-04-08Labeling · Supplement 32 · standard — Label ↗AP
2013-12-20Efficacy · Supplement 31 · priority — Label ↗AP
2013-10-24Labeling · Supplement 30 · standard — Letter ↗AP
2013-08-05Labeling · Supplement 29 · standard — Label ↗AP
2013-06-28Efficacy · Supplement 27 · standard — Letter ↗AP
2013-04-04Labeling · Supplement 28 · standard — Label ↗AP
2012-08-10Labeling · Supplement 26 · 901 required — Label ↗AP
2012-04-18Efficacy · Supplement 23 · standard — Letter ↗AP
2012-03-28Efficacy · Supplement 21 · standard — Label ↗AP
2011-12-21Efficacy · Supplement 22 · priority — Label ↗AP
2011-11-02Labeling · Supplement 20 · standard — Letter ↗AP
2011-06-10Labeling · Supplement 15 · unknown — Letter ↗AP
2011-04-11Labeling · Supplement 18 · standard — Label ↗AP
2011-02-24Labeling · Supplement 17 · standard — Label ↗AP
2010-06-29Efficacy · Supplement 12 · standard — Letter ↗AP
2010-06-29Efficacy · Supplement 11 · standard — Label ↗AP
2010-03-26Labeling · Supplement 14 · unknown — Letter ↗AP
2009-11-04Labeling · Supplement 13 · unknown — Label ↗AP
2009-07-08Efficacy · Supplement 4 · unknown — Label ↗AP
2009-01-29Efficacy · Supplement 1 · standard — Label ↗AP
2009-01-13Labeling · Supplement 6 · standard — Letter ↗AP
2008-10-24Labeling · Supplement 3 · standard — Label ↗AP
2007-10-12Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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