FDA.reportPublic FDA data

Application 021226

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KALETRALOPINAVIR; RITONAVIRCAPSULE;ORAL133.3MG;33.3MGNoNo

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
N021226-001KALETRALOPINAVIR; RITONAVIR133.3MG;33.3MGCAPSULE / ORAL2000-09-15

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 22:38:342026-08N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-1584e616aacf4f…
2026-08-18 06:07:402026-07N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-1587673890dc5c…
2021-03-12 10:30 UTC2021-03N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-153f01610625f2…
2019-09-15 20:21 UTC2019-09N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-15b00525d2431f…
2019-07-19 19:46 UTC2019-07N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-153f0d92c62455…
2023-05-13 08:27 UTC2023-05N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-15053a50430f4f…
2023-01-26 05:58 UTC2023-01N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021226-001KALETRA133.3MG;33.3MGCAPSULE / ORAL2000-09-15f41ea6bd6efb…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021226-00171415932020-05-22Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021226-00174322942020-05-22Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021226-0017141593*PED2020-11-22Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021226-0017432294*PED2020-11-22Pediatric extension74a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021226-00171415932020-05-22Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021226-00174322942020-05-22Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021226-0017141593*PED2020-11-22Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021226-0017432294*PED2020-11-22Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N021226-00171415932020-05-22Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021226-00174322942020-05-22Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021226-0017141593*PED2020-11-22Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N021226-0017432294*PED2020-11-22Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N021226-00171415932020-05-22Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021226-00174322942020-05-22Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021226-0017141593*PED2020-11-22Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N021226-0017432294*PED2020-11-22Pediatric 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 reactionsName fallback
brand name: Kaletra

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65008SUPPL2020-10-23
65007SUPPL2020-10-23
64977SUPPL2020-10-22
61426SUPPL2019-12-23
61424SUPPL2019-12-23
61406SUPPL2019-12-23
59820SUPPL2019-08-22
59813SUPPL2019-08-22
59812SUPPL2019-08-22
56687SUPPL2018-12-07
56536SUPPL2018-11-23
48743SUPPL2017-06-16
48737SUPPL2017-06-16
48736SUPPL2017-06-16
46000SUPPL2016-12-02
45944SUPPL2016-11-23
45378SUPPL2016-09-20
45340SUPPL2016-09-20
4688SUPPL2015-11-13
14672SUPPL2015-11-12
27126SUPPL2015-07-06
36403SUPPL2015-07-01
14671SUPPL2015-04-02
27127SUPPL2015-04-01
36402SUPPL2013-11-08
27125SUPPL2013-11-08
36401SUPPL2013-01-22
4687SUPPL2013-01-22
36400SUPPL2012-06-28
4686SUPPL2012-06-28
27124SUPPL2012-02-27
36399SUPPL2012-02-22
27123SUPPL2010-06-09
36398SUPPL2010-05-07
27122SUPPL2007-10-04
42038SUPPL2007-09-26
36397SUPPL2007-09-26
21524SUPPL2007-09-26
21523SUPPL2007-09-26
4685SUPPL2007-07-16
36396SUPPL2007-07-10
36395SUPPL2007-04-25
27120SUPPL2007-04-25
27121SUPPL2007-01-08
14670SUPPL2006-12-28
27118SUPPL2005-05-03
14668SUPPL2005-05-03
27119SUPPL2005-03-30
14669SUPPL2005-03-30
36394SUPPL2004-10-26
4684SUPPL2004-10-26
27117SUPPL2003-12-08
14667SUPPL2003-12-08
36393SUPPL2002-11-27
42037SUPPL2002-01-18
36392SUPPL2002-01-18
27116SUPPL2002-01-18
27115SUPPL2001-03-13
21522SUPPL2001-03-13
14666SUPPL2001-03-13
36391ORIG2000-09-15
23067ORIG2000-09-15
21521ORIG2000-09-15
4683ORIG2000-09-15
67143SUPPL1900-01-01
67142SUPPL1900-01-01
67140SUPPL1900-01-01
63991ORIG1900-01-01
63990ORIG1900-01-01
63989ORIG1900-01-01
63988ORIG1900-01-01
63987ORIG1900-01-01
63986ORIG1900-01-01
63985ORIG1900-01-01
51341ORIG1900-01-01
51340ORIG1900-01-01
51316ORIG1900-01-01