← FDA DRUG APPROVALS

FDA NDA · NDA021251

KALETRA

lopinavir and ritonavir

Sponsor: ABBVIE

APPLICATION
NDA021251
TYPE
NDA
ORIGINAL APPROVAL
2000-09-15
LATEST ACTION
2026-07-23
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

KALETRA · ReferencePrescription
LOPINAVIR 80MG/ML, RITONAVIR 20MG/ML · SOLUTION · ORAL

Approval history

2026-07-23Labeling · Supplement 60 · standard — Letter ↗AP
2020-10-21Labeling · Supplement 59 · standard — Letter ↗AP
2019-12-19Labeling · Supplement 58 · standard — Letter ↗AP
2019-08-21Labeling · Supplement 57 · standard — Letter ↗AP
2018-11-15Labeling · Supplement 56 · standard — Label ↗AP
2017-10-13Labeling · Supplement 55 · standard — Label ↗AP
2017-06-15Labeling · Supplement 54 · standard — Label ↗AP
2016-11-22Labeling · Supplement 52 · standard — Letter ↗AP
2016-09-15Labeling · Supplement 53 · 901 required — Label ↗AP
2015-11-10Labeling · Supplement 51 · standard — Letter ↗AP
2015-06-26Efficacy · Supplement 49 · standard — Letter ↗AP
2015-03-27Labeling · Supplement 50 · 901 required — Label ↗AP
2015-01-28Efficacy · Supplement 47 · standard — Letter ↗AP
2013-11-07Labeling · Supplement 46 · standard — Letter ↗AP
2013-01-17Labeling · Supplement 45 · standard — Label ↗AP
2012-05-16Labeling · Supplement 44 · standard — Letter ↗AP
2012-04-20Labeling · Supplement 41 · standard — Letter ↗AP
2012-02-17Labeling · Supplement 42 · 901 required — Label ↗AP
2011-05-06REMS · Supplement 40 — Letter ↗AP
2011-02-24Labeling · Supplement 39 · standard — Label ↗AP
2010-06-14Labeling · Supplement 33 · unknown — Letter ↗AP
2010-04-27Efficacy · Supplement 31 · standard — Letter ↗AP
2010-01-29Labeling · Supplement 29 · standard — Letter ↗AP
2009-04-20Efficacy · Supplement 26 · standard — Label ↗AP
2009-04-06Labeling · Supplement 23 · standard — Letter ↗AP
2008-10-03Labeling · Supplement 24 · standard — Label ↗AP
2008-07-30Labeling · Supplement 17 · standard — Letter ↗AP
2008-06-20Efficacy · Supplement 22 · priority — Pediatric Written Request ↗AP
2007-11-09Efficacy · Supplement 18 · priority — Letter ↗AP
2007-09-25Labeling · Supplement 19 · standard — Letter ↗AP
2007-06-29Labeling · Supplement 16 · standard — Label ↗AP
2007-04-20Efficacy · Supplement 12 · unknown — Label ↗AP
2007-03-02Labeling · Supplement 14 · standard — Label ↗AP
2006-12-21Labeling · Supplement 13 · standard — Letter ↗AP
2005-03-28Labeling · Supplement 11 · standard — Label ↗AP
2004-10-19Efficacy · Supplement 10 · unknown — Review ↗AP
2003-12-03Labeling · Supplement 9 · standard — Letter ↗AP
2002-12-24Manufacturing (CMC) · Supplement 6 · priorityAP
2002-11-27Efficacy · Supplement 5 · standard — Review ↗AP
2002-01-18Efficacy · Supplement 3 · standardAP
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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