← FDA DRUG APPROVALS

FDA NDA · NDA201152

VIRAMUNE XR

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA201152
TYPE
NDA
ORIGINAL APPROVAL
2011-03-25
LATEST ACTION
2024-07-22
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

VIRAMUNE XR · ReferenceDiscontinued
NEVIRAPINE 100MG · TABLET, EXTENDED RELEASE · ORAL
VIRAMUNE XR · ReferenceDiscontinued
NEVIRAPINE 400MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-07-22Labeling · Supplement 15 · standard — Letter ↗AP
2022-06-10Labeling · Supplement 14 · standard — Letter ↗AP
2018-09-24Labeling · Supplement 13 · standard — Label ↗AP
2017-03-27Labeling · Supplement 10 · standard — Label ↗AP
2014-01-27Labeling · Supplement 7 · standard — Letter ↗AP
2012-11-08Efficacy · Supplement 4 · standard — Letter ↗AP
2012-09-28Efficacy · Supplement 5 · standard — Letter ↗AP
2011-11-09Labeling · Supplement 2 · standard — Label ↗AP
2011-05-06REMS · Supplement 1 — Letter ↗AP
2011-03-25Type 3 - New Dosage Form · Original · standard — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →