Application 021252

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CANASAMESALAMINESUPPOSITORY;RECTAL500MGNoNo
002CANASAMESALAMINESUPPOSITORY;RECTAL1GMYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021252-001CANASAMESALAMINE500MGSUPPOSITORY / RECTAL2001-01-05
N021252-002CANASAMESALAMINE1GMSUPPOSITORY / RECTALABRLD, RS2004-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021252-002AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021252-00282170832028-06-06Drug product2013-05-24
N021252-00284360512028-06-06Drug product2013-05-24

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-05d06236e962d9…
2024-10-29 15:01 UTC2024-10N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-05bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-05782e0a99824c…
2021-12-28 21:50 UTC2021-12N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-05782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021252-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021252-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021252-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021252-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021252-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021252-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021252-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021252-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021252-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021252-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021252-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021252-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021252-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021252-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021252-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021252-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021252-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021252-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021252-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021252-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021252-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021252-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021252-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021252-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021252-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021252-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021252-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021252-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021252-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021252-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021252-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021252-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021252-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021252-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021252-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021252-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021252-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021252-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021252-002AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021252-002AB1cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021252-00282170832028-06-06Drug product2013-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021252-00284360512028-06-06Drug product2013-05-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021252-00282170832028-06-06Drug product2013-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021252-00284360512028-06-06Drug product2013-05-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021252-00282170832028-06-06Drug product2013-05-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021252-00284360512028-06-06Drug product2013-05-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021252-00282170832028-06-06Drug product2013-05-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021252-00284360512028-06-06Drug product2013-05-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021252-00282170832028-06-06Drug product2013-05-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021252-00284360512028-06-06Drug product2013-05-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021252-00282170832028-06-06Drug product2013-05-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021252-00284360512028-06-06Drug product2013-05-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021252-00282170832028-06-06Drug product2013-05-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021252-00284360512028-06-06Drug product2013-05-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021252-00282170832028-06-06Drug product2013-05-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021252-00284360512028-06-06Drug product2013-05-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021252-00282170832028-06-06Drug product2013-05-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021252-00284360512028-06-06Drug product2013-05-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021252-00282170832028-06-06Drug product2013-05-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N021252-00284360512028-06-06Drug product2013-05-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021252-00282170832028-06-06Drug product2013-05-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021252-00284360512028-06-06Drug product2013-05-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021252-00282170832028-06-06Drug product2013-05-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021252-00284360512028-06-06Drug product2013-05-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021252-00282170832028-06-06Drug product2013-05-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021252-00284360512028-06-06Drug product2013-05-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021252-00282170832028-06-06Drug product2013-05-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021252-00284360512028-06-06Drug product2013-05-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021252-00282170832028-06-06Drug product2013-05-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021252-00284360512028-06-06Drug product2013-05-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021252-00282170832028-06-06Drug product2013-05-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021252-00284360512028-06-06Drug product2013-05-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021252-00282170832028-06-06Drug product2013-05-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021252-00284360512028-06-06Drug product2013-05-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021252-00282170832028-06-06Drug product2013-05-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021252-00284360512028-06-06Drug product2013-05-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021252-00282170832028-06-06Drug product2013-05-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021252-00284360512028-06-06Drug product2013-05-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021252-00282170832028-06-06Drug product2013-05-24782e0a99824c…
2021-12-28 21:50 UTC2021-12N021252-00284360512028-06-06Drug product2013-05-24782e0a99824c…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N021252-001M-1872019-09-0274a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021252-001M-1872019-09-023f01610625f2…
2019-09-15 20:21 UTC2019-09N021252-001M-1872019-09-02b00525d2431f…
2019-07-19 19:46 UTC2019-07N021252-001M-1872019-09-02ea99ee380514…

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
CanasaMESALAMINEAllergan, Inc.89d91601-152b-4398-bebe-af1c023e99352024-09-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 021252
application number: NDA021252
ndc (product): 58914-501

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58914-501CanasaMesalamineAllergan, Inc.NDACurrent
58914-501CanasaMesalamineAllergan, Inc.NDACurrent
58914-501CanasaMesalamineAllergan, Inc.NDACurrent
58914-501CanasaMesalamineAllerganNDACurrent
59762-0118MesalaminemesalamineGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0118MesalaminemesalamineGreenstone LLCNDACurrent
59762-0118MesalaminemesalamineGreenstone LLCNDACurrent
59762-0118MesalaminemesalamineGreenstone LLCNDACurrent
65084-474CanasaMesalamineMckesson Rxpak IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75943SUPPL 2023-10-25
75928SUPPL 2023-10-25
72644SUPPL2022-11-17
72628SUPPL2022-11-17
69205SUPPL2021-11-02
69198SUPPL2021-11-02
64864SUPPL2020-10-07
64798SUPPL2020-10-02
49183SUPPL2017-08-02
49141SUPPL2017-07-31
45228SUPPL2016-09-02
45203SUPPL2016-09-02
27223SUPPL2013-12-20
14752SUPPL2013-12-19
14751SUPPL2013-02-08
27222SUPPL2013-02-07
27221SUPPL2008-05-28
4779SUPPL2006-06-12
36468SUPPL2004-11-08
4777SUPPL2004-11-08
4778SUPPL2004-09-29
4776SUPPL2003-10-17
36467ORIG2003-04-08
21550ORIG2001-01-05
4775ORIG2001-01-05
51339ORIG1900-01-01
51338ORIG1900-01-01
51337ORIG1900-01-01