Application 021830

Type
NDA
Sponsor
APIL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ASACOL HDMESALAMINETABLET, DELAYED RELEASE;ORAL800MGYesYes

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
N021830-001ASACOL HDMESALAMINE800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29

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 22:38:342026-08N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-2984e616aacf4f…
2026-08-18 06:07:402026-07N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALRLD2008-05-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-293f01610625f2…
2019-09-15 20:21 UTC2019-09N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALRLD2008-05-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALRLD2008-05-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALRLD2008-05-29f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-08 23:34 UTC2022-04N021830-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021830-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021830-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021830-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021830-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021830-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021830-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021830-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021830-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021830-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021830-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021830-001AB1ea99ee380514…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021830-00168936622021-11-15U-141Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021830-00185803022021-11-15Drug product2013-11-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021830-00190894922021-11-15Drug product2015-09-2274a2ff9319b5…
2021-12-28 21:50 UTC2021-12N021830-00168936622021-11-15U-141Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021830-00185803022021-11-15Drug product2013-11-13782e0a99824c…
2021-12-28 21:50 UTC2021-12N021830-00190894922021-11-15Drug product2015-09-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021830-00168936622021-11-15U-141Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021830-00185803022021-11-15Drug product2013-11-1387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021830-00190894922021-11-15Drug product2015-09-2287673890dc5c…
2021-03-12 10:30 UTC2021-03N021830-00168936622021-11-15U-141Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021830-00185803022021-11-15Drug product2013-11-135aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021830-00190894922021-11-15Drug product2015-09-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021830-00168936622021-11-15U-141Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021830-00185803022021-11-15Drug product2013-11-138869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021830-00190894922021-11-15Drug product2015-09-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021830-00168936622021-11-15U-141Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021830-00185803022021-11-15Drug product2013-11-13c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021830-00190894922021-11-15Drug product2015-09-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021830-00168936622021-11-15U-141Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021830-00185803022021-11-15Drug product2013-11-133f01610625f2…
2019-12-14 00:12 UTC2019-12N021830-00190894922021-11-15Drug product2015-09-223f01610625f2…
2019-09-15 20:21 UTC2019-09N021830-00168936622021-11-15U-141Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021830-00185803022021-11-15Drug product2013-11-13b00525d2431f…
2019-09-15 20:21 UTC2019-09N021830-00190894922021-11-15Drug product2015-09-22b00525d2431f…
2019-07-19 19:46 UTC2019-07N021830-00168936622021-11-15U-141Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021830-00185803022021-11-15Drug product2013-11-13ea99ee380514…
2019-07-19 19:46 UTC2019-07N021830-00190894922021-11-15Drug product2015-09-22ea99ee380514…

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 3 of 4 · 64 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MesalamineMESALAMINEPadagis Israel Pharmaceuticals Ltdd50f2c37-5675-49f3-bdd4-3b16d333ed402024-08-01Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
MesalamineMESALAMINEPadagis Israel Pharmaceuticals Ltda4ddf68d-1502-4242-89aa-c96436bdcbf62024-08-01Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
MesalamineMESALAMINEAscend Laboratories, LLC43f69db3-81ac-4da4-a61f-fbba6299d9c22024-07-03Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
MesalamineMESALAMINETeva Pharmaceuticals, Inc.e3b84397-a5a5-40cf-8145-0584103d465f2024-06-28Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
MesalamineMESALAMINEBryant Ranch Prepack06792d20-d7e9-4b66-a4cb-cd0cf1a2db252024-06-28Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
MesalamineMESALAMINERising Pharma Holdings, Inc.de981df1-747a-480d-a866-e72332a1544d2024-06-14Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
MESALAMINEMESALAMINEBryant Ranch Prepack063ca661-1b5c-4941-a5b9-5dd0fa46b3d02024-05-29Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
MesalamineMESALAMINEAmneal Pharmaceuticals LLC00f77203-3615-47e8-ae25-6e1cf8a2a00a2024-05-23Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
MesalamineMESALAMINEBryant Ranch Prepackc9b1ef9d-1d06-48e7-87d2-7985b99124a62024-05-01Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
mesalamineMESALAMINEGolden State Medical Supply, Inc.170657d1-1f32-f036-e063-6294a90a4ed42024-04-26Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
MESALAMINEMESALAMINELannett Company Inc.29dbe417-15a9-4c4d-846b-81cabda7ac702024-02-29Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
MesalamineMESALAMINECamber Pharmaceuticals, Inc.efa9d039-ae1f-4cd6-98f2-e87a901dfaeb2024-02-26Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
MesalamineMESALAMINECamber Pharmaceuticals, Inc.04ce2182-2e8c-4598-a269-550cfaddde6c2024-02-15Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
MesalamineMESALAMINEANI Pharmaceuticals, Inc.3cf751f2-a0c9-45d7-8acb-2bc61db0e4ac2024-02-14Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
MesalamineMESALAMINEAurobindo Pharma Limitedd6c0fc76-644e-4301-9672-f432061e3d372024-01-20Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
MESALAMINEMESALAMINEAlembic Pharmaceuticals Inc.87d3d62d-2dc3-4e6f-be33-cabbca12e8f72024-01-09Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
mesalamineMESALAMINETeva Pharmaceuticals USA, Inc.8d27a608-3ba1-4799-be38-c00fb08ce3ce2023-12-19Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
Mesalamine RectalMESALAMINEAmring Pharmaceuticals Inc.87de237c-febb-42ca-b2a4-b444396f86402023-12-15Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
MesalamineMESALAMINESun Pharmaceutical Industries, Inc.fd8b02de-7dfa-444d-a1f8-1436b578e0cb2023-12-01Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
MesalamineMESALAMINEMylan Pharmaceuticals Inc.c8b93ea3-0367-4605-b87f-06c3812ff3b72023-11-30Warnings, Adverse reactionsName fallback
generic name: MESALAMINE

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-5901Asacol HDmesalamineAllergan, Inc.NDACurrent
0023-5901Asacol HDmesalamineAllergan, Inc.NDACurrent
0023-5901Asacol HDmesalamineAllergan, Inc.NDACurrent
0023-5901Asacol HDmesalamineAllergan, Inc.NDACurrent
0023-5901Asacol HDmesalamineAllergan, Inc.NDACurrent
0023-5901Asacol HDmesalamineAllergan, Inc.NDACurrent
0023-5901Asacol HDmesalamineAllergan, Inc.NDACurrent
0023-5901Asacol HDmesalamineAllergan, Inc.NDACurrent
0430-0783ASACOL HDmesalamineAllergan, Inc.NDACurrent
50090-3497mesalaminemesalamineA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3497mesalaminemesalamineA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3497mesalaminemesalamineA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
59762-0117MESALAMINEMESALAMINEGreenstone LLCNDACurrent
60687-347mesalaminemesalamineAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
68382-484mesalaminemesalamineZydus Pharmaceuticals (USA) Inc.NDA AUTHORIZED GENERICCurrent
68382-649mesalaminemesalamineZydus Pharmaceuticals (USA) Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72645SUPPL2022-11-17
72627SUPPL2022-11-17
69194SUPPL2021-11-02
69183SUPPL2021-11-02
64849SUPPL2020-10-06
64800SUPPL2020-10-02
64107SUPPL2020-07-28
53769SUPPL2018-04-23
53742SUPPL2018-04-19
49139SUPPL2017-07-28
49125SUPPL2017-07-28
16431SUPPL2016-05-06
6275SUPPL2016-05-06
37734SUPPL2013-10-22
28674SUPPL2013-10-21
37733SUPPL2012-05-14
28673SUPPL2010-05-28
21837ORIG2009-05-15
37732SUPPL2009-04-28
28672SUPPL2009-04-27
24220ORIG2008-07-17
37731ORIG2008-06-12
28671ORIG2008-06-03
51336SUPPL1900-01-01
51335SUPPL1900-01-01
51334SUPPL1900-01-01