Application 019651
- Type
- NDA
- Sponsor
- APIL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ASACOL | MESALAMINE | TABLET, DELAYED RELEASE;ORAL | 400MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019651-001 | ASACOL | MESALAMINE | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N019651-001 | ASACOL | 400MG | TABLET, DELAYED RELEASE / ORAL | 1992-01-31 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Mesalamine | MESALAMINE | Actavis Pharma, Inc. | ba1e3bd4-fbe0-46a5-961e-167ccb09672c | 2025-03-27 | Warnings, Adverse reactions | MESALAMINE |
| Pentasa | MESALAMINE | Takeda Pharmaceuticals America, Inc. | e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606 | 2025-01-15 | Warnings, Adverse reactions | MESALAMINE |
| Mesalamine | MESALAMINE | Northstar Rx LLC. | 7ac78fa0-60a8-48dd-abc4-a487f98039a2 | 2025-01-10 | Warnings, Adverse reactions | MESALAMINE |
| Mesalamine | MESALAMINE | Takeda Pharmaceuticals America, Inc. | 4e3b6325-a5bf-4c47-931c-142c0e4d7c3a | 2025-01-09 | Warnings, Adverse reactions | MESALAMINE |
| Mesalamine | MESALAMINE | AvPAK | f2657911-6f06-71fb-e053-2a95a90ae6f7 | 2025-01-09 | Warnings, Adverse reactions | MESALAMINE |
| Mesalamine | MESALAMINE | Zydus Lifesciences Limited | aa63b4bb-2de7-40aa-b26b-1b00b0183eac | 2025-01-09 | MESALAMINE | |
| Mesalamine | MESALAMINE | Zydus Pharmaceuticals USA Inc. | f458d574-7b5b-44f1-86be-8b18880dc67f | 2025-01-08 | Warnings, Adverse reactions | MESALAMINE |
| mesalamine | MESALAMINE | Zydus Lifesciences Limited | 29c0dd58-d2cf-40fa-bc32-0eab61937331 | 2024-11-30 | MESALAMINE | |
| mesalamine | MESALAMINE | Zydus Lifesciences Limited | 52d96501-47f3-45d8-a181-98763b9f8965 | 2024-11-30 | MESALAMINE | |
| Mesalamine | MESALAMINE | Zydus Lifesciences Limited | 04073681-a834-4f45-91c5-224b608b30e6 | 2024-11-30 | MESALAMINE | |
| Mesalamine | MESALAMINE | American Health Packaging | 77140634-9f32-40ca-8c83-9fcc3e373c16 | 2024-11-22 | Warnings, Adverse reactions | MESALAMINE |
| Mesalamine | MESALAMINE | NorthStar RxLLC | 8233f158-9da5-4fd2-b2c3-9db89448371f | 2024-11-21 | Warnings, Adverse reactions | MESALAMINE |
| Mesalamine | MESALAMINE | American Health Packaging | a74ab9f4-ffcd-4bbf-88a5-342e6a38aabb | 2024-11-21 | Warnings, Adverse reactions | MESALAMINE |
| Mesalamine | MESALAMINE | Bryant Ranch Prepack | 1e561474-6169-410e-b83d-7e96d375831d | 2024-11-07 | Warnings, Adverse reactions | MESALAMINE |
| Mesalamine | MESALAMINE | Bryant Ranch Prepack | 9756d07b-2939-460f-94d3-e338c28cb993 | 2024-11-07 | Warnings, Adverse reactions | MESALAMINE |
| Mesalamine | MESALAMINE | Bryant Ranch Prepack | b48df65a-a717-479e-9122-8b0f1406c841 | 2024-11-01 | Warnings, Adverse reactions | MESALAMINE |
| Canasa | MESALAMINE | Allergan, Inc. | 89d91601-152b-4398-bebe-af1c023e9935 | 2024-09-08 | Warnings, Adverse reactions | MESALAMINE |
| Mesalamine | MESALAMINE | Sun Pharmaceutical Industries Inc. | c2f84490-70b8-4998-907d-a77e9f791de1 | 2024-08-27 | Warnings, Adverse reactions | MESALAMINE |
| Mesalamine | MESALAMINE | Bryant Ranch Prepack | baa76dde-3c5b-4ff4-ba0c-f19660a796c1 | 2024-08-14 | Warnings, Adverse reactions | MESALAMINE |
| Mesalamine | MESALAMINE | Padagis Israel Pharmaceuticals Ltd | b2a5b110-7537-4ffc-bf0a-f0fe13379c9d | 2024-08-01 | Warnings, Adverse reactions | MESALAMINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 53808-0205 | Asacol | mesalamine | State of Florida DOH Central Pharmacy | NDA | Current |
| 53808-0823 | ASACOL | mesalamine | State of Florida DOH Central Pharmacy | NDA | Current |
| 55154-2305 | Asacol | mesalamine | Cardinal Health | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 64793 | SUPPL | 2020-10-02 |
| 64789 | SUPPL | 2020-10-02 |
| 49138 | SUPPL | 2017-07-28 |
| 49123 | SUPPL | 2017-07-28 |
| 11600 | SUPPL | 2015-05-29 |
| 17519 | SUPPL | 2015-05-28 |
| 11599 | SUPPL | 2013-10-22 |
| 1460 | SUPPL | 2013-10-21 |
| 11598 | SUPPL | 2010-05-28 |
| 1459 | SUPPL | 2010-05-28 |
| 17518 | SUPPL | 2009-11-12 |
| 33838 | SUPPL | 2009-10-06 |
| 1458 | SUPPL | 2007-04-20 |
| 20277 | SUPPL | 2003-06-18 |