FDA NDA · NDA201917

INCIVEK

Sponsor: VERTEX PHARMS

APPLICATION

NDA201917

TYPE

NDA

ORIGINAL APPROVAL

2011-05-23

LATEST ACTION

2014-03-25

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

INCIVEKDiscontinued

TELAPREVIR 375MG · TABLET · ORAL

2014-03-25Manufacturing (CMC) · Supplement 13 · priorityAP

2013-10-28Labeling · Supplement 12 · standard — Label ↗AP

2013-10-28Efficacy · Supplement 10 · standard — Letter ↗AP

2013-07-22Manufacturing (CMC) · Supplement 11 · priorityAP

2013-05-08Manufacturing (CMC) · Supplement 9 · priorityAP

2013-04-25Labeling · Supplement 8 · standard — Label ↗AP

2012-12-14Labeling · Supplement 7 · standard — Letter ↗AP

2012-11-27Manufacturing (CMC) · Supplement 5 · priorityAP

2012-06-22Labeling · Supplement 4 · standard — Label ↗AP

2012-03-22Labeling · Supplement 3 · standard — Label ↗AP

2011-05-23Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priority — Review ↗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.

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