Application 022285

Type
NDA
Sponsor
UCB INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KEPPRA XRLEVETIRACETAMTABLET, EXTENDED RELEASE;ORAL500MGYesNo
002KEPPRA XRLEVETIRACETAMTABLET, EXTENDED RELEASE;ORAL750MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022285-001KEPPRA XRLEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-12
N022285-002KEPPRA XRLEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N022285-001AB
N022285-002AB

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022285-00178581222028-09-17Drug product2011-01-07
N022285-00278581222028-09-17Drug product

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 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-12c2088c7a36db…
2026-10-15 13:18:302026-09N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-12c2088c7a36db…
2026-09-14 22:38:342026-08N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-1284e616aacf4f…
2026-09-14 22:38:342026-08N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-1284e616aacf4f…
2026-08-18 06:07:402026-07N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-12caaa826d4ba7…
2026-08-18 06:07:402026-07N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-124b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N022285-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09N022285-002AB1c2088c7a36db…
2026-09-14 22:38:342026-08N022285-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N022285-002AB184e616aacf4f…
2026-08-18 06:07:402026-07N022285-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N022285-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022285-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022285-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022285-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022285-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022285-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022285-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022285-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022285-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022285-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022285-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022285-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022285-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022285-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022285-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022285-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022285-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022285-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022285-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022285-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N022285-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022285-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022285-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022285-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022285-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022285-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022285-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022285-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022285-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022285-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022285-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022285-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022285-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022285-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022285-002AB14b0b4de00fa7…

Observed Orange Book patent history#

Patent history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N022285-00178581222028-09-17Drug product2011-01-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022285-00278581222028-09-17Drug product74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022285-00178581222028-09-17Drug product2011-01-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022285-00278581222028-09-17Drug productbb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022285-00178581222028-09-17Drug product2011-01-07782e0a99824c…
2021-12-28 21:50 UTC2021-12N022285-00278581222028-09-17Drug product782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022285-00178581222028-09-17Drug product2011-01-0787673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022285-00278581222028-09-17Drug product87673890dc5c…
2021-03-12 10:30 UTC2021-03N022285-00178581222028-09-17Drug product2011-01-075aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022285-00278581222028-09-17Drug product5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022285-00178581222028-09-17Drug product2011-01-078869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022285-00278581222028-09-17Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022285-00178581222028-09-17Drug product2011-01-07c0c555d07b60…
2020-11-12 02:37 UTC2020-11N022285-00278581222028-09-17Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N022285-00178581222028-09-17Drug product2011-01-073f01610625f2…
2019-12-14 00:12 UTC2019-12N022285-00278581222028-09-17Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N022285-00178581222028-09-17Drug product2011-01-07b00525d2431f…
2019-09-15 20:21 UTC2019-09N022285-00278581222028-09-17Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N022285-00178581222028-09-17Drug product2011-01-07ea99ee380514…
2019-07-19 19:46 UTC2019-07N022285-00278581222028-09-17Drug productea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022285-00178581222028-09-17Drug product2011-01-076a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022285-00278581222028-09-17Drug product6a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022285-00178581222028-09-17Drug product2011-01-071c564ffb4f44…
2024-02-18 07:12 UTC2024-02N022285-00278581222028-09-17Drug product1c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022285-00178581222028-09-17Drug product2011-01-07ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N022285-00278581222028-09-17Drug productea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022285-00178581222028-09-17Drug product2011-01-07a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022285-00278581222028-09-17Drug producta72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022285-00178581222028-09-17Drug product2011-01-079b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022285-00278581222028-09-17Drug product9b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022285-00178581222028-09-17Drug product2011-01-07a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022285-00278581222028-09-17Drug producta67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022285-00178581222028-09-17Drug product2011-01-073f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022285-00278581222028-09-17Drug product3f0d92c62455…
2023-05-13 08:27 UTC2023-05N022285-00178581222028-09-17Drug product2011-01-07053a50430f4f…
2023-05-13 08:27 UTC2023-05N022285-00278581222028-09-17Drug product053a50430f4f…
2023-01-26 05:58 UTC2023-01N022285-00178581222028-09-17Drug product2011-01-073bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N022285-00278581222028-09-17Drug product3bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022285-00178581222028-09-17Drug product2011-01-073a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022285-00278581222028-09-17Drug product3a93d1ddd44b…

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
Keppra XRLEVETIRACETAMUCB, Inc.2919e43b-69a8-434c-a2d2-1f3ecd7554c02025-06-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 022285
application number: NDA022285
ndc (product): 50474-599
ndc (product): 50474-598

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50474-598KeppralevetiracetamUCB, Inc.NDACurrent
50474-598KeppralevetiracetamUCB, Inc.NDACurrent
50474-598KeppralevetiracetamUCB, Inc.NDACurrent
50474-598KeppralevetiracetamUCB, Inc.NDACurrent
50474-598KeppralevetiracetamUCB, Inc.NDACurrent
50474-599KeppralevetiracetamUCB, Inc.NDACurrent
50474-599KeppralevetiracetamUCB, Inc.NDACurrent
50474-599KeppralevetiracetamUCB, Inc.NDACurrent
50474-599KeppralevetiracetamUCB, Inc.NDACurrent
50474-599KeppralevetiracetamUCB, Inc.NDACurrent
65084-460KeppralevetiracetamMckesson Rxpak IncNDACurrent
65084-461KeppralevetiracetamMckesson Rxpak IncNDACurrent
70518-2109KeppralevetiracetamREMEDYREPACK INC.NDACurrent
70518-2109KeppralevetiracetamREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77821SUPPL 2024-03-13
77793SUPPL 2024-03-13
77792SUPPL 2024-03-13
75140SUPPL 2023-08-18
75120SUPPL 2023-08-18
64809SUPPL2020-10-02
64808SUPPL2020-10-02
64780SUPPL2020-10-01
60655SUPPL2019-10-24
60651SUPPL2019-10-24
60649SUPPL2019-10-24
50219SUPPL2017-10-30
50173SUPPL2017-10-25
48143SUPPL2017-04-27
48106SUPPL2017-04-25
45763SUPPL2016-11-01
45705SUPPL2016-10-28
29527SUPPL2016-04-08
17198SUPPL2016-04-07
29524SUPPL2015-03-12
17196SUPPL2015-03-12
29526SUPPL2014-08-11
17197SUPPL2014-08-08
38503SUPPL2014-08-04
29525SUPPL2014-08-04
7176SUPPL2014-03-11
7175SUPPL2014-03-11
38504SUPPL2014-03-10
38502SUPPL2014-03-10
38501SUPPL2013-07-30
38500SUPPL2013-07-30
29523SUPPL2013-07-26
7173SUPPL2013-07-26
7174SUPPL2011-08-12
38499SUPPL2009-05-12
38498SUPPL2009-05-12
7172SUPPL2009-05-04
7171SUPPL2009-05-04
7170SUPPL2009-02-18
38497SUPPL2009-02-13
42478ORIG2009-01-06
24274ORIG2009-01-06
44180ORIG2008-09-19
38496ORIG2008-09-16
7169ORIG2008-09-16
51297SUPPL1900-01-01
51296SUPPL1900-01-01
51295SUPPL1900-01-01
51294SUPPL1900-01-01