Home Applications 022301 Application 022301
Type NDA
Sponsor VALEANT PHARMS INTL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 APRISO MESALAMINE CAPSULE, EXTENDED RELEASE;ORAL 375MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022301-001 APRISO MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD, RS 2008-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022301-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022301-001 8865688 2030-05-01 U-1310 2014-10-22
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 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N022301-001 APRISO 375MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD, RS 2008-10-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022301-001 APRISO 375MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD, RS 2008-10-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022301-001 APRISO 375MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD, RS 2008-10-31 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022301-001 APRISO 375MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD, RS 2008-10-31 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 3a93d1ddd44b…
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.
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 · 27 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0093-9224 mesalamine mesalamine Teva Pharmaceuticals USA, Inc.- NDA AUTHORIZED GENERIC Current 0093-9224 mesalamine mesalamine Teva Pharmaceuticals USA, Inc. NDA AUTHORIZED GENERIC Current 0093-9224 mesalamine mesalamine Teva Pharmaceuticals USA, Inc. NDA AUTHORIZED GENERIC Current 0093-9224 mesalamine mesalamine Teva Pharmaceuticals USA, Inc. NDA AUTHORIZED GENERIC Current 43353-884 APRISO mesalamine Aphena Pharma Solutions - Tennessee, LLC NDA Current 63629-8827 mesalamine mesalamine Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 63629-8827 mesalamine mesalamine Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 65649-103 APRISO mesalamine Salix Pharmaceuticals, Inc. NDA Current 65649-103 APRISO mesalamine Salix Pharmaceuticals, Inc. NDA Current 65649-103 APRISO mesalamine Salix Pharmaceuticals, Inc. NDA Current 65649-103 APRISO mesalamine Salix Pharmaceuticals, Inc. NDA Current 65649-103 APRISO mesalamine Salix Pharmaceuticals, Inc. NDA Current 65649-103 APRISO mesalamine Salix Pharmaceuticals, Inc. NDA Current 65649-103 APRISO mesalamine Salix Pharmaceuticals, Inc. NDA Current 65649-103 APRISO mesalamine Salix Pharmaceuticals, In NDA Current 65649-103 APRISO mesalamine Salix Pharmaceuticals, Inc. NDA Current 65649-103 APRISO mesalamine Salix Pharmaceuticals, Inc. NDA Current 68682-113 mesalamine mesalamine Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-113 mesalamine mesalamine Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-113 mesalamine mesalamine Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-113 mesalamine mesalamine Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-113 mesalamine mesalamine Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-113 mesalamine mesalamine Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 70748-214 mesalamine mesalamine Lupin Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 70748-214 mesalamine mesalamine Lupin Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 70748-214 mesalamine mesalamine Lupin Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 70748-214 mesalamine mesalamine Lupin Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current