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FDA NDA · NDA205786

ISENTRESS

raltegravir

Sponsor: MSD SUB MERCK

APPLICATION
NDA205786
TYPE
NDA
ORIGINAL APPROVAL
2013-12-20
LATEST ACTION
2021-05-18
ROUTE
ORAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

ISENTRESS · ReferencePrescription
RALTEGRAVIR POTASSIUM EQ 100MG BASE/PACKET · POWDER · ORAL

Approval history

2021-05-18Labeling · Supplement 9 · standard — Letter ↗AP
2020-07-14Efficacy · Supplement 8 · standard — Label ↗AP
2018-03-05Labeling · Supplement 7 · standard — Label ↗AP
2017-11-22Efficacy · Supplement 6 · priority — Label ↗AP
2017-05-26Efficacy · Supplement 4 · standard — Label ↗AP
2015-02-20Labeling · Supplement 3 · standard — Label ↗AP
2015-02-18Labeling · Supplement 2 · standard — Label ↗AP
2014-04-08Labeling · Supplement 1 · standard — Label ↗AP
2013-12-20Type 3 - New Dosage Form · Original · priority — Label ↗AP
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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