FDA NDA · NDA021814

APTIVUS

Sponsor: BOEHRINGER INGELHEIM

APPLICATION

NDA021814

TYPE

NDA

ORIGINAL APPROVAL

2005-06-22

LATEST ACTION

2024-04-03

ROUTE

ORAL

DOSAGE FORM

CAPSULE

MARKETING STATUS

Prescription

Products

APTIVUS · ReferencePrescription

TIPRANAVIR 250MG · CAPSULE · ORAL

2024-04-03Labeling · Supplement 30 · standard — Label ↗AP

2020-06-18Labeling · Supplement 21 · standard — Letter ↗AP

2018-06-22Labeling · Supplement 18 · standard — Label ↗AP

2016-09-15Labeling · Supplement 16 · 901 required — Letter ↗AP

2015-03-27Labeling · Supplement 15 · 901 order — Label ↗AP

2014-04-07Labeling · Supplement 14 · standard — Label ↗AP

2012-02-17Labeling · Supplement 13 · 901 required — Label ↗AP

2011-04-05Labeling · Supplement 11 · standard — Letter ↗AP

2010-08-16Labeling · Supplement 9 · standard — Letter ↗AP

2010-04-27Labeling · Supplement 8 · unknown — Letter ↗AP

2009-06-19Labeling · Supplement 6 · standard — Label ↗AP

2008-06-23Efficacy · Supplement 5 · priority — Review ↗AP

2007-10-04Efficacy · Supplement 3 · unknown — Label ↗AP

2007-05-14Labeling · Supplement 4 · standard — Letter ↗AP

2006-08-11Labeling · Supplement 1 · standard — Letter ↗AP

2006-08-11Labeling · Supplement 2 · standard — Label ↗AP

2005-06-22Type 1 - New Molecular Entity · 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.

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