← FDA DRUG APPROVALS

FDA NDA · NDA203045

ISENTRESS

raltegravir

Sponsor: MSD SUB MERCK

APPLICATION
NDA203045
TYPE
NDA
ORIGINAL APPROVAL
2011-12-21
LATEST ACTION
2021-05-18
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Prescription

Products

ISENTRESS · ReferencePrescription
RALTEGRAVIR POTASSIUM EQ 100MG BASE · TABLET, CHEWABLE · ORAL
ISENTRESS · ReferencePrescription
RALTEGRAVIR POTASSIUM EQ 25MG BASE · TABLET, CHEWABLE · ORAL

Approval history

2021-05-18Labeling · Supplement 17 · standard — Letter ↗AP
2020-07-14Efficacy · Supplement 16 · standard — Label ↗AP
2018-03-05Labeling · Supplement 15 · standard — Label ↗AP
2017-11-22Efficacy · Supplement 14 · priority — Label ↗AP
2017-05-26Efficacy · Supplement 13 · standard — Label ↗AP
2015-02-20Labeling · Supplement 12 · standard — Label ↗AP
2015-02-18Labeling · Supplement 11 · standard — Label ↗AP
2014-04-08Labeling · Supplement 10 · standard — Label ↗AP
2013-12-20Efficacy · Supplement 9 · priority — Label ↗AP
2013-10-24Labeling · Supplement 8 · standard — Label ↗AP
2013-08-05Labeling · Supplement 7 · standard — Label ↗AP
2013-06-28Efficacy · Supplement 4 · standard — Label ↗AP
2013-05-28Manufacturing (CMC) · Supplement 6 · priorityAP
2013-04-04Labeling · Supplement 5 · standard — Letter ↗AP
2012-08-10Labeling · Supplement 3 · 901 required — Label ↗AP
2012-04-18Efficacy · Supplement 2 · standard — Label ↗AP
2012-03-28Efficacy · Supplement 1 · standard — Label ↗AP
2011-12-21Type 3 - New Dosage Form · Original · priority — Summary 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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