← FDA DRUG APPROVALS

FDA NDA · NDA021226

KALETRA

Sponsor: ABBVIE

APPLICATION
NDA021226
TYPE
NDA
ORIGINAL APPROVAL
2000-09-15
LATEST ACTION
2020-10-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

KALETRADiscontinued
LOPINAVIR 133.3MG, RITONAVIR 33.3MG · CAPSULE · ORAL

Approval history

2020-10-21Labeling · Supplement 49 · standard — Letter ↗AP
2019-12-19Labeling · Supplement 48 · standard — Letter ↗AP
2019-08-21Labeling · Supplement 47 · standard — Label ↗AP
2018-11-15Labeling · Supplement 46 · standard — Label ↗AP
2017-06-15Labeling · Supplement 45 · standard — Label ↗AP
2016-11-22Labeling · Supplement 43 · standard — Letter ↗AP
2016-09-15Labeling · Supplement 44 · 901 required — Letter ↗AP
2015-11-10Labeling · Supplement 42 · standard — Letter ↗AP
2015-06-26Efficacy · Supplement 40 · standard — Pediatric Medical Review ↗AP
2015-03-27Labeling · Supplement 41 · 901 required — Label ↗AP
2013-11-07Labeling · Supplement 38 · standard — Letter ↗AP
2013-01-17Labeling · Supplement 37 · standard — Label ↗AP
2012-06-27Labeling · Supplement 36 · standard — Letter ↗AP
2012-02-17Labeling · Supplement 35 · 901 required — Letter ↗AP
2010-04-27Labeling · Supplement 30 · 901 required — Letter ↗AP
2007-09-26Labeling · Supplement 22 · standard — Letter ↗AP
2007-07-09Labeling · Supplement 20 · standard — Letter ↗AP
2007-04-20Efficacy · Supplement 18 · unknown — Letter ↗AP
2006-12-21Labeling · Supplement 19 · standard — Label ↗AP
2005-04-29Efficacy · Supplement 16 · unknown — Label ↗AP
2005-03-28Labeling · Supplement 17 · standard — Label ↗AP
2004-10-19Efficacy · Supplement 14 · unknown — Label ↗AP
2003-12-03Labeling · Supplement 12 · standard — Label ↗AP
2002-12-24Manufacturing (CMC) · Supplement 7 · priorityAP
2002-11-27Efficacy · Supplement 6 · standard — Label ↗AP
2002-02-13Manufacturing (CMC) · Supplement 5 · priorityAP
2002-01-18Efficacy · Supplement 3 · standard — Label ↗AP
2002-01-18Efficacy · Supplement 4 · standardAP
2001-03-13Labeling · Supplement 2 · standard — Label ↗AP
2001-01-30Labeling · Supplement 1 · standardAP
2000-09-15Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priority — Pediatric Medical Review ↗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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