Application 203634

Type
NDA
Sponsor
SALIX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001UCERISBUDESONIDETABLET, EXTENDED RELEASE;ORAL9MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N203634-001UCERISBUDESONIDE9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N203634-001AB

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N203634-001103073752031-09-07Drug product2019-06-14
N203634-001106608582031-09-07Drug product2020-07-21
N203634-00188950642031-09-07Drug product2014-11-25
N203634-00191320932031-09-07Drug product2015-09-16
N203634-00191925812031-09-07U-1325Drug product2015-12-03

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-1487673890dc5c…
2021-03-12 10:30 UTC2021-03N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-143f01610625f2…
2019-09-15 20:21 UTC2019-09N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-14b00525d2431f…
2019-07-19 19:46 UTC2019-07N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-143f0d92c62455…
2023-05-13 08:27 UTC2023-05N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-14053a50430f4f…
2023-01-26 05:58 UTC2023-01N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-14e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N203634-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N203634-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203634-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N203634-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203634-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203634-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203634-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203634-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203634-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203634-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N203634-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203634-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203634-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N203634-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N203634-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N203634-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N203634-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N203634-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N203634-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N203634-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N203634-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N203634-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N203634-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N203634-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N203634-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N203634-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N203634-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N203634-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N203634-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N203634-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N203634-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N203634-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N203634-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N203634-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N203634-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N203634-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N203634-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N203634-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N203634-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N203634-001AB1e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 7 · 266 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N203634-001103073752031-09-07Drug product2019-06-14caaa826d4ba7…
2026-08-18 06:07:402026-07N203634-001106608582031-09-07Drug product2020-07-21caaa826d4ba7…
2026-08-18 06:07:402026-07N203634-00188950642031-09-07Drug product2014-11-25caaa826d4ba7…
2026-08-18 06:07:402026-07N203634-00191320932031-09-07Drug product2015-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07N203634-00191925812031-09-07U-1325Drug product2015-12-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N203634-001103073752031-09-07Drug product2019-06-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203634-001106608582031-09-07Drug product2020-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203634-00188950642031-09-07Drug product2014-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203634-00191320932031-09-07Drug product2015-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203634-00191925812031-09-07U-1325Drug product2015-12-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203634-001103073752031-09-07Drug product2019-06-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203634-001106608582031-09-07Drug product2020-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203634-00188950642031-09-07Drug product2014-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203634-00191320932031-09-07Drug product2015-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203634-00191925812031-09-07U-1325Drug product2015-12-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N203634-001103073752031-09-07Drug product2019-06-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203634-001106608582031-09-07Drug product2020-07-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203634-00188950642031-09-07Drug product2014-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203634-00191320932031-09-07Drug product2015-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203634-00191925812031-09-07U-1325Drug product2015-12-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203634-001103073752031-09-07Drug product2019-06-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203634-001106608582031-09-07Drug product2020-07-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203634-00188950642031-09-07Drug product2014-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203634-00191320932031-09-07Drug product2015-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203634-00191925812031-09-07U-1325Drug product2015-12-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203634-001103073752031-09-07Drug product2019-06-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203634-001106608582031-09-07Drug product2020-07-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203634-00188950642031-09-07Drug product2014-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203634-00191320932031-09-07Drug product2015-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203634-00191925812031-09-07U-1325Drug product2015-12-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203634-001103073752031-09-07Drug product2019-06-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203634-001106608582031-09-07Drug product2020-07-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203634-00188950642031-09-07Drug product2014-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203634-00191320932031-09-07Drug product2015-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203634-00191925812031-09-07U-1325Drug product2015-12-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203634-001103073752031-09-07Drug product2019-06-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203634-001106608582031-09-07Drug product2020-07-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203634-00188950642031-09-07Drug product2014-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203634-00191320932031-09-07Drug product2015-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203634-00191925812031-09-07U-1325Drug product2015-12-032680178bc6a6…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
budesonideBUDESONIDEOceanside Pharmaceuticalsa12b2e99-c8b3-4d08-9af0-8c4a4376ebf12024-10-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 203634
application number: NDA203634
ndc (product): 68682-309
UcerisBUDESONIDESantarus Inc.92cbb190-8851-46ed-bfe0-166ca62ef2e92024-10-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 203634
application number: NDA203634
ndc (product): 68012-309

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68012-309UcerisbudesonideSantarus Inc.NDACurrent
68012-309UcerisbudesonideSantarus Inc.NDACurrent
68012-309UcerisbudesonideSantarus Inc.NDACurrent
68012-309UcerisbudesonideSantarus Inc.NDACurrent
68682-309budesonidebudesonideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-309budesonidebudesonideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-309budesonidebudesonideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78723SUPPL 2024-07-02
78661SUPPL 2024-06-06
62560SUPPL2020-04-14
62526SUPPL2020-04-10
45613SUPPL2016-10-17
45548SUPPL2016-10-17
24443ORIG2013-07-08
22930ORIG2013-07-08
32454ORIG2013-01-16
40317ORIG2013-01-15