FDA.reportPublic FDA data

Application 021251

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KALETRALOPINAVIR; RITONAVIRSOLUTION;ORAL80MG/ML;20MG/MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021251-001KALETRALOPINAVIR; RITONAVIR80MG/ML;20MG/MLSOLUTION / ORALRLD, RS2000-09-15

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALRLD, RS2000-09-1584e616aacf4f…
2026-08-18 06:07:402026-07N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALRLD, RS2000-09-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALRLD, RS2000-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-1587673890dc5c…
2021-03-12 10:30 UTC2021-03N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-153f01610625f2…
2019-09-15 20:21 UTC2019-09N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-15b00525d2431f…
2019-07-19 19:46 UTC2019-07N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-153f0d92c62455…
2023-05-13 08:27 UTC2023-05N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-15053a50430f4f…
2023-01-26 05:58 UTC2023-01N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021251-001KALETRA80MG/ML;20MG/MLSOLUTION / ORALAARLD, RS2000-09-15f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021251-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021251-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021251-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021251-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021251-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021251-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021251-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021251-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021251-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021251-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021251-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021251-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021251-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021251-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021251-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021251-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021251-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021251-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021251-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021251-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03N021251-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021251-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021251-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021251-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09N021251-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021251-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021251-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021251-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021251-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021251-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021251-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021251-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021251-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021251-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021251-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021251-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021251-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021251-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021251-001AA1cb3db0bc1861…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021251-00169112142021-11-28U-895Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021251-00185012192021-11-28Drug product2013-08-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021251-0016911214*PED2022-05-28Pediatric extension74a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021251-00169112142021-11-28U-895Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021251-00185012192021-11-28Drug product2013-08-263f01610625f2…
2019-12-14 00:12 UTC2019-12N021251-0016911214*PED2022-05-28Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N021251-00169112142021-11-28U-895Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021251-00185012192021-11-28Drug product2013-08-26b00525d2431f…
2019-09-15 20:21 UTC2019-09N021251-0016911214*PED2022-05-28Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N021251-00169112142021-11-28U-895Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021251-00185012192021-11-28Drug product2013-08-26ea99ee380514…
2019-07-19 19:46 UTC2019-07N021251-0016911214*PED2022-05-28Pediatric extensionea99ee380514…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KaletraLOPINAVIR AND RITONAVIRAbbVie Inc.8290add3-4449-4e58-6c97-8fe1eec972e32026-07-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 021251
application number: NDA021251
ndc (product): 0074-3956

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-3956KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-3956KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-3956KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-3956KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-3956KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-3956KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-3956KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-3956KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-3956KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-3956KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65010SUPPL2020-10-23
65009SUPPL2020-10-23
64989SUPPL2020-10-23
61431SUPPL2019-12-23
61430SUPPL2019-12-23
61396SUPPL2019-12-23
59817SUPPL2019-08-22
59809SUPPL2019-08-22
56688SUPPL2018-12-07
56537SUPPL2018-11-23
50082SUPPL2017-10-18
50079SUPPL2017-10-18
50075SUPPL2017-10-18
48745SUPPL2017-06-16
48734SUPPL2017-06-16
45967SUPPL2016-11-29
45945SUPPL2016-11-23
45331SUPPL2016-09-20
45322SUPPL2016-09-15
4774SUPPL2015-11-17
14750SUPPL2015-11-12
27219SUPPL2015-07-06
36466SUPPL2015-07-01
14749SUPPL2015-04-02
27220SUPPL2015-04-01
36465SUPPL2015-01-30
4773SUPPL2015-01-29
36464SUPPL2013-11-08
27218SUPPL2013-11-08
36463SUPPL2013-01-22
27217SUPPL2013-01-22
4772SUPPL2012-05-18
14748SUPPL2012-05-17
14746SUPPL2012-04-24
4771SUPPL2012-04-24
27216SUPPL2012-02-27
14747SUPPL2012-02-22
4770SUPPL2011-05-10
36462SUPPL2011-03-04
4769SUPPL2011-03-01
27215SUPPL2010-06-16
36461SUPPL2010-06-15
36460SUPPL2010-05-07
4768SUPPL2010-05-03
4767SUPPL2010-02-05
14745SUPPL2010-02-04
27214SUPPL2009-04-24
14744SUPPL2009-04-23
14742SUPPL2009-04-16
4766SUPPL2009-04-10
14743SUPPL2008-10-09
27213SUPPL2008-10-08
4763SUPPL2008-08-05
14741SUPPL2008-06-26
27212SUPPL2008-06-24
52942SUPPL2008-03-07
52941SUPPL2008-03-07
52322SUPPL2008-03-07
52321SUPPL2008-03-07
52320SUPPL2008-03-07
52319SUPPL2008-03-07
52318SUPPL2008-03-07
52317SUPPL2008-03-07
52316SUPPL2008-03-07
36459SUPPL2007-11-19
4764SUPPL2007-11-19
4765SUPPL2007-10-04
42055SUPPL2007-09-26
21549SUPPL2007-09-26
14740SUPPL2007-09-26
27211SUPPL2007-07-05
14739SUPPL2007-07-05
27208SUPPL2007-04-25
14737SUPPL2007-04-25
27210SUPPL2007-03-07
14738SUPPL2007-03-07
27209SUPPL2007-01-08
36458SUPPL2006-12-28
27207SUPPL2005-03-30
14736SUPPL2005-03-30
36457SUPPL2004-10-26
27206SUPPL2004-10-26
14735SUPPL2003-12-08
4762SUPPL2003-12-08
14734SUPPL2002-11-27
42054SUPPL2002-01-18
36456SUPPL2002-01-18
27205SUPPL2002-01-18
42053SUPPL2001-03-13
36455SUPPL2001-03-13
27204SUPPL2001-03-13
23070ORIG2000-09-15
21548ORIG2000-09-15
14733ORIG2000-09-15
4761ORIG2000-09-15