FDA NDA · NDA202258

VICTRELIS

Sponsor: MERCK SHARP DOHME

APPLICATION

NDA202258

TYPE

NDA

ORIGINAL APPROVAL

2011-05-13

LATEST ACTION

2017-01-30

ROUTE

ORAL

DOSAGE FORM

CAPSULE

MARKETING STATUS

Discontinued

Products

VICTRELISDiscontinued

BOCEPREVIR 200MG · CAPSULE · ORAL

2017-01-30Labeling · Supplement 16 · standard — Label ↗AP

2014-07-28Labeling · Supplement 15 · standard — Label ↗AP

2014-04-09Efficacy · Supplement 11 · standard — Letter ↗AP

2014-02-24Labeling · Supplement 14 · standard — Letter ↗AP

2014-02-07Labeling · Supplement 13 · standard — Label ↗AP

2014-01-17Labeling · Supplement 12 · standard — Label ↗AP

2013-09-18Labeling · Supplement 9 · standard — Label ↗AP

2013-07-22Manufacturing (CMC) · Supplement 8 · priorityAP

2013-02-27Efficacy · Supplement 4 · standard — Label ↗AP

2013-02-15Labeling · Supplement 7 · standard — Letter ↗AP

2013-02-13Efficacy · Supplement 3 · standard — Label ↗AP

2012-12-21Labeling · Supplement 6 · standard — Label ↗AP

2012-11-02Labeling · Supplement 5 · standard — Letter ↗AP

2012-07-30Labeling · Supplement 1 · standard — Label ↗AP

2012-04-20Labeling · Supplement 2 · standard — Label ↗AP

2011-05-13Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priority — Label ↗AP

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

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