← FDA DRUG APPROVALS

FDA NDA · NDA202022

EDURANT

rilpivirine hydrochloride

Sponsor: JANSSEN PRODS

APPLICATION
NDA202022
TYPE
NDA
ORIGINAL APPROVAL
2011-05-20
LATEST ACTION
2024-03-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

EDURANT · ReferencePrescription
RILPIVIRINE HYDROCHLORIDE EQ 25MG BASE · TABLET · ORAL

Approval history

2024-03-15Efficacy · Supplement 22 · priority — Label ↗AP
2024-03-15Efficacy · Supplement 20 · priority — Label ↗AP
2022-10-19Labeling · Supplement 19 · standard — Letter ↗AP
2022-03-29Efficacy · Supplement 18 · priority — Letter ↗AP
2022-03-29Efficacy · Supplement 17 · priority — Letter ↗AP
2022-01-31Efficacy · Supplement 16 · standard — Letter ↗AP
2021-01-21Efficacy · Supplement 14 · priority — Letter ↗AP
2019-05-14Labeling · Supplement 13 · standard — Letter ↗AP
2018-02-01Efficacy · Supplement 11 · priority — Label ↗AP
2017-09-15Labeling · Supplement 10 · standard — Label ↗AP
2015-08-26Efficacy · Supplement 8 · priority — Pediatric Medical Review ↗AP
2015-05-05Labeling · Supplement 9 · 901 required — Label ↗AP
2014-05-01Labeling · Supplement 7 · standard — Label ↗AP
2013-07-23Manufacturing (CMC) · Supplement 6 · standardAP
2013-06-21Labeling · Supplement 5 · standard — Label ↗AP
2013-04-26Manufacturing (CMC) · Supplement 4 · standardAP
2012-12-07Efficacy · Supplement 2 · standard — Label ↗AP
2012-08-10Labeling · Supplement 3 · 901 required — Label ↗AP
2011-05-20Type 1 - New Molecular Entity · Original · standard — Label ↗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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