| These highlights do not include all the information needed to use MESALAMINE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MESALAMINE EXTENDED-RELEASE CAPSULES. MESALAMINE extended-release capsules Initial U.S. Approval: 1987 | Product name | Ascend Laboratories, LLC | Alkem Laboratories Limited | 2026-10-19 |
| These highlights do not include all the information needed to use MESALAMINE RECTAL SUSPENSION safely and effectively. See full prescribing information for MESALAMINE RECTAL SUSPENSION. MESALAMINE rectal suspension Initial U.S. Approval: 1987 | Product name | KLM Laboratories Private Limited | 2026-10-07 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE CAPSULES. MESALAMINE delayed-release capsules, for oral use Initial U.S. Approval: 1987 | Product name | American Health Packaging | 2026-09-17 |
| These highlights do not include all the information needed to use APRISO safely and effectively. See full prescribing information for APRISO. APRISO ® (mesalamine) extended-release capsules Initial U.S. Approval: 1987 | Product name | Salix Pharmaceuticals, Inc. | Catalent Pharma Solutions, LLC | Bausch Health Companies Inc. | 2026-08-27 |
| These highlights do not include all the information needed to use ROWASA safely and effectively. See full prescribing information for ROWASA . ROWASA (mesalamine) rectal suspension Initial U.S. Approval: 1987 | Product name | Viatris Specialty LLC | 2026-08-03 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE Delayed-Release Tablets, for oral use Initial U.S. Approval: 1987 | Product name | Major Pharmaceuticals | 2026-07-27 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE delayed-release tablets, for oral use Initial U.S. Approval: 1987 | Product name | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2026-07-14 |
| These highlights do not include all the information needed to use MESALAMINE RECTAL SUSPENSION safely and effectively. See full prescribing information for MESALAMINE RECTAL SUSPENSION. MESALAMINE rectal suspension Initial U.S. Approval: 1987 | Product name | ANI Pharmaceuticals, Inc. | 2026-05-20 |
| These highlights do not include all the information needed to use MESALAMINE RECTAL SUSPENSION safely and effectively. See full prescribing information for MESALAMINE RECTAL SUSPENSION. MESALAMINE rectal suspension Initial U.S. Approval: 1987 | Product name | KLM Laboratories Private Limited | 2026-04-01 |
| These highlights do not include all the information needed to use LIALDA safely and effectively. See full prescribing information for LIALDA. LIALDA ® (mesalamine) delayed-release tablets, for oral use Initial U.S. Approval: 1987 | Product name | Takeda Pharmaceuticals America, Inc. | Sharp Packaging Services LLC | PharmaZell GmbH | Cosmo SpA | PharmaZell (India) Private Ltd. | 2026-03-24 |
| MESALAMINE EXTENDED-RELEASE CAPSULES. These highlights do not include all the information needed to use MESALAMINE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MESALAMINE EXTENDED-RELEASE CAPSULES. MESALAMINE extended-release capsules, for oral use Initial U.S. Approval: 1987 | Product name | Golden State Medical Supply, Inc. | 2026-03-05 |
| These highlights do not include all the information needed to use LIALDA safely and effectively. See full prescribing information for LIALDA. LIALDA ® (mesalamine) delayed-release tablets, for oral use Initial U.S. Approval: 1987 | Product name | Takeda Pharmaceuticals America, Inc. | Sharp Packaging Services LLC | PharmaZell GmbH | Cosmo SpA | PharmaZell (India) Private Ltd. | 2026-03-05 |
| These highlights do not include all the information needed to use MESALAMINE SUPPOSITORIES safely and effectively. See full prescribing information for MESALAMINE SUPPOSITORIES. MESALAMINE suppositories, for rectal use Initial U.S. Approval: 1987 | Product name | Actavis Pharma, Inc. | 2026-02-24 |
| Mesalamine Delayed-Release Tablets, USP Rx only These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. Initial U.S. Approval: 1987 | Product name | AvKARE | 2026-01-14 |
| MESALAMINE Delayed-Release Tablets, USP These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE Delayed-Release Tablets, for oral use Initial U.S. Approval: 1987 | Product name | Chartwell RX, LLC | 2025-12-17 |
| These highlights do not include all the information needed to use LIALDA safely and effectively. See full prescribing information for LIALDA. LIALDA ® (mesalamine) delayed-release tablets, for oral use Initial U.S. Approval: 1987 | Product name | Takeda Pharmaceuticals America, Inc. | Sharp Packaging Services LLC | PharmaZell GmbH | Cosmo SpA | PharmaZell (India) Private Ltd. | 2025-12-16 |
| These highlights do not include all the information needed to use MESALAMINE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MESALAMINE EXTENDED-RELEASE CAPSULES. MESALAMINE extended-release capsules, for oral use Initial U.S. Approval: 1987 | Product name | Camber Pharmaceuticals, Inc. | Annora Pharma Private Limited | 2025-12-10 |
| These highlights do not include all the information needed to use MESALAMINE SUPPOSITORIES safely and effectively. See full prescribing information for MESALAMINE SUPPOSITORIES. MESALAMINE suppositories, for rectal use Initial U.S. Approval: 1987 | Product name | Rising Pharma Holdings, Inc. | Bliss GVS Pharma Limited | 2025-12-10 |
| These highlights do not include all the information needed to use MESALAMINE EXTENDED-RELEASE CAPSULES s afely and effectively. See full prescribing information for MESALAMINE EXTENDED-RELEASE CAPSULES . MESALAMINE extended-release capsules, for oral use Initial U.S. Approval: 1987 | Product name | Ingenus Pharmaceuticals, LLC | Novast Laboratories, Ltd. | 2025-12-05 |
| These highlights do not include all the information needed to use MESALAMINE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MESALAMINE EXTENDED-RELEASE CAPSULES. MESALAMINE extended-release capsules, for oral use Initial U.S. Approval: 1987 | Product name | Upsher-Smith Laboratories, LLC | AMTA LABS LIMITED | Yichang Humanwell Oral Solid Dosage Plant | 2025-12-01 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE Delayed-Release Tablets, for oral use Initial U.S. Approval: 1987 | Product name | Northstar Rx LLC. | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2025-11-14 |
| These highlights do not include all the information needed to use MESALAMINE RECTAL SUSPENSION ENEMA safely and effectively. See full prescribing information for MESALAMINE RECTALSUSPENSION ENEMA. MESALAMINE rectal suspension enema Initial U.S. Approval: 1987 | Product name | Encube Ethicals, Inc. | Encube Ethicals Private Limited | 2025-10-07 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE Delayed-Release Tablets, for oral use Initial U.S. Approval: 1987 | Product name | Major Pharmaceuticals | 2025-09-15 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE CAPSULES. MESALAMINE delayed-release capsules, for oral use Initial U.S. Approval: 1987 | Product name | Teva Pharmaceuticals USA, Inc. | 2025-05-30 |
| These highlights do not include all the information needed to use MESALAMINE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MESALAMINE EXTENDED-RELEASE CAPSULES. MESALAMINE extended-release capsules Initial U.S. Approval: 1987 | Product name | American Health Packaging | 2025-05-21 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE delayed-release tablets, for oral use Initial U.S. Approval: 1987 | Product name | Actavis Pharma, Inc. | 2025-03-27 |
| These highlights do not include all the information needed to use PENTASA safely and effectively. See full prescribing information for PENTASA. PENTASA ® (mesalamine) extended-release capsules, for oral use Initial U.S. Approval: 1987 | Product name | Takeda Pharmaceuticals America, Inc. | Patheon Manufacturing Services LLC | PharmaZell GmbH | Syntese A/S | Sharp Packaging Services, LLC | 2025-01-15 |
| These highlights do not include all the information needed to use MESALAMINE SUPPOSITORIES safely and effectively. See full prescribing information for MESALAMINE SUPPOSITORIES. MESALAMINE suppositories, for rectal use Initial U.S. Approval: 1987 | Product name | Northstar Rx LLC. | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2025-01-10 |
| Mesalamine Extended Release Rx Only These highlights do not include all the information needed to use MESALAMINE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MESALAMINE EXTENDED-RELEASE CAPSULES. Initial U.S. Approval: 1987 | Product name | AvPAK | 2025-01-09 |
| MESALAMINE SUPPOSITORIES | Product name | Zydus Lifesciences Limited | 2025-01-09 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE delayed-release tablets, for oral use Initial U.S. Approval: 1987 | Product name | Takeda Pharmaceuticals America, Inc. | Cosmo SpA | Sharp Packaging Services, LLC | PharmaZell GmbH | PharmaZell (India) Private Ltd. | 2025-01-09 |
| These highlights do not include all the information needed to use MESALAMINE SUPPOSITORIES safely and effectively. See full prescribing information for MESALAMINE SUPPOSITORIES. MESALAMINE suppositories, for rectal use Initial U.S. Approval: 1987 | Product name | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2025-01-08 |
| MESALAMINE DELAYED-RELEASE TABLETS | Product name | Zydus Lifesciences Limited | 2024-11-30 |
| MESALAMINE DELAYED-RELEASE TABLETS | Product name | Zydus Lifesciences Limited | 2024-11-30 |
| MESALAMINE Extended-Release Capsules | Product name | Zydus Lifesciences Limited | 2024-11-30 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE Delayed-Release Tablets, for oral use Initial U.S. Approval: 1987 | Product name | American Health Packaging | 2024-11-22 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE delayed-release tablets, for oral use Initial U.S. Approval: 1987 | Product name | NorthStar RxLLC | Annora Pharma Private Limited | 2024-11-21 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE delayed-release tablets, for oral use Initial U.S. Approval: 1987 | Product name | American Health Packaging | 2024-11-21 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE CAPSULES. MESALAMINE delayed-release capsules, for oral use Initial U.S. Approval: 1987 | Product name | American Health Packaging | 2024-11-14 |
| Mesalamine Rectal Suspension, USP Enema | Product name | Bryant Ranch Prepack | 2024-11-07 |
| Mesalamine Rectal Suspension, USP Enema | Product name | Bryant Ranch Prepack | 2024-11-07 |
| These highlights do not include all the information needed to use MESALAMINE SUPPOSITORIES safely and effectively. See full prescribing information for MESALAMINE SUPPOSITORIES. MESALAMINE suppositories, for rectal use Initial U.S. Approval: 1987 | Product name | Bryant Ranch Prepack | 2024-11-01 |
| These highlights do not include all the information needed to use CANASA safely and effectively. See full prescribing information for CANASA. CANASA ® (mesalamine) suppositor ies, for rectal use Initial U.S. Approval: 1987 | Product name | Allergan, Inc. | 2024-09-08 |
| These highlights do not include all the information needed to use MESALAMINE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MESALAMINE EXTENDED-RELEASE CAPSULES. MESALAMINE extended-release capsules, for oral use Initial U.S. Approval: 1987 | Product name | Sun Pharmaceutical Industries Inc. | Sun Pharmaceutical Industries Limited | 2024-08-27 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE delayed-release tablets, for oral use Initial U.S. Approval: 1987 | Product name | Bryant Ranch Prepack | 2024-08-14 |
| These highlights do not include all the information needed to use MESALAMINE RECTAL SUSPENSION ENEMA safely and effectively. See full prescribing information for MESALAMINE RECTAL SUSPENSION ENEMA. MESALAMINE rectal suspension enema Initial U.S. Approval: 1987 | Product name | Padagis Israel Pharmaceuticals Ltd | 2024-08-01 |
| These highlights do not include all the information needed to use MESALAMINE RECTAL SUSPENSION ENEMA safely and effectively. See full prescribing information for MESALAMINE RECTAL SUSPENSION ENEMA. MESALAMINE rectal suspension enema Initial U.S. Approval: 1987 | Product name | Padagis Israel Pharmaceuticals Ltd | 2024-08-01 |
| These highlights do not include all the information needed to use MESALAMINE RECTAL SUSPENSION ENEMA safely and effectively. See full prescribing information for MESALAMINE RECTAL SUSPENSION ENEMA. MESALAMINE rectal suspension enema Initial U.S. Approval: 1987 | Product name | Padagis Israel Pharmaceuticals Ltd | 2024-08-01 |
| These highlights do not include all the information needed to use sfROWASA safely and effectively. See full prescribing information for sfROWASA. sfROWASA® (mesalamine) rectal suspension sulfite-free formulation Initial U.S. Approval: 1987 | Product name | Viatris Specialty LLC | 2024-07-24 |
| These highlights do not include all the information needed to use ROWASA safely and effectively. See full prescribing information for ROWASA . ROWASA (mesalamine) rectal suspension Initial U.S. Approval: 1987 | Product name | Viatris Specialty LLC | 2024-07-15 |
| These highlights do not include all the information needed to use MESALAMINE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MESALAMINE EXTENDED-RELEASE CAPSULES. MESALAMINE extended-release capsules Initial U.S. Approval: 1987 | Product name | Ascend Laboratories, LLC | Alkem Laboratories Limited | 2024-07-03 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS . MESALAMINE delayed-release tablets , for oral use Initial U.S. Approval: 1987 | Product name | Teva Pharmaceuticals, Inc. | 2024-06-28 |
| These highlights do not include all the information needed to use MESALAMINE SUPPOSITORIES safely and effectively. See full prescribing information for MESALAMINE SUPPOSITORIES. MESALAMINE suppositories, for rectal use Initial U.S. Approval: 1987 | Product name | Bryant Ranch Prepack | 2024-06-28 |
| These highlights do not include all the information needed to use MESALAMINE SUPPOSITORIES safely and effectively. See full prescribing information for MESALAMINE SUPPOSITORIES. MESALAMINE suppositories, for rectal use Initial U.S. Approval: 1987 | Product name | Rising Pharma Holdings, Inc. | Halo Pharmaceuticals, Inc. | 2024-06-14 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE delayed-release tablets, for oral use Initial U.S. Approval: 1987 | Product name | Bryant Ranch Prepack | 2024-05-29 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE delayed-release tablets, for oral use Initial U.S. Approval: 1987 | Product name | Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals of New York, LLC | 2024-05-23 |
| Mesalamine Rectal Suspension, USP Enema 4 grams/unit (60 mL) | Product name | Bryant Ranch Prepack | 2024-05-01 |
| MESALAMINE DELAYED-RELEASE TABLETS. These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE Delayed-Release Tablets, for oral use Initial U.S. Approval: 1987 | Product name | Golden State Medical Supply, Inc. | 2024-04-26 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE delayed-release tablets, for oral use Initial U.S. Approval: 1987 | Product name | Lannett Company Inc. | Sinotherapeutics Inc. | Haimen Pharma Inc. | 2024-02-29 |
| These highlights do not include all the information needed to use MESALAMINE SUPPOSITORIES safely and effectively. See full prescribing information for MESALAMINE SUPPOSITORIES. MESALAMINE suppositories, for rectal use Initial U.S. Approval: 1987 | Product name | Camber Pharmaceuticals, Inc. | Annora Pharma Private Limited | 2024-02-26 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE delayed-release tablets, for oral use Initial U.S. Approval: 1987 | Product name | Camber Pharmaceuticals, Inc. | Annora Pharma Private Limited | 2024-02-15 |
| Mesalamine Rectal Suspension Enema 4 grams/unit (60 mL) | Product name | ANI Pharmaceuticals, Inc. | 2024-02-14 |
| These highlights do not include all the information needed to use MESALAMINE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MESALAMINE EXTENDED-RELEASE CAPSULES. MESALAMINE extended-release capsules, for oral use Initial U.S. Approval: 1987 | Product name | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 2024-01-20 |
| These highlights do not include all the information needed to use APRISO safely and effectively. See full prescribing information for APRISO. APRISO ® (mesalamine) extended-release capsules Initial U.S. Approval: 1987 | Product name | Salix Pharmaceuticals, Inc. | Catalent Pharma Solutions, LLC | Bausch Health Companies Inc. | 2024-01-09 |
| These highlights do not include all the information needed to use MESALAMINE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MESALAMINE EXTENDED-RELEASE CAPSULES. MESALAMINE extended-release capsules, for oral use Initial U.S. Approval: 1987 | Product name | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | 2024-01-09 |
| These highlights do not include all the information needed to use MESALAMINE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MESALAMINE EXTENDED-RELEASE CAPSULES. MESALAMINE extended-release capsules Initial U.S. Approval: 1987 | Product name | Teva Pharmaceuticals USA, Inc. | Catalent Pharma Solutions, LLC | Bausch Health Companies Inc. | 2023-12-19 |
| These highlights do not include all the information needed to use MESALAMINE RECTAL SUPPOSITORIES safely and effectively. See full prescribing information for MESALAMINE RECTAL SUPPOSITORIES. MESALAMINE suppositories, for rectal use Initial U.S. Approval: 1987 | Product name | Amring Pharmaceuticals Inc. | Confab Laboratories Inc. | 2023-12-15 |
| Mesalamine Rectal Suspension, USP Enema 4 grams/unit (60 mL) | Product name | Encube Ethicals Private Limited | 2023-12-04 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE delayed-release tablets, for oral use Initial U.S. Approval: 1987 | Product name | Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited | 2023-12-01 |
| These highlights do not include all the information needed to use MESALAMINE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MESALAMINE EXTENDED-RELEASE CAPSULES . MESALAMINE extended-release capsules, for oral use Initial U.S. Approval: 1987 | Product name | Mylan Pharmaceuticals Inc. | 2023-11-30 |
| These highlights do not include all the information needed to use MESALAMINE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MESALAMINE EXTENDED-RELEASE CAPSULES . MESALAMINE extended-release capsules, for oral use Initial U.S. Approval: 1987 | Product name | Mylan Pharmaceuticals Inc. | 2023-11-30 |
| These highlights do not include all the information needed to use MESALAMINE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MESALAMINE EXTENDED-RELEASE CAPSULES. MESALAMINE extended-release capsules Initial U.S. Approval: 1987 | Product name | Oceanside Pharmaceuticals | Catalent Pharma Solutions, LLC | Bausch Health Companies Inc. | 2023-10-31 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE Delayed-Release Tablets, for oral use Initial U.S. Approval: 1987 | Product name | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2023-10-26 |
| These highlights do not include all the information needed to use MESALAMINE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MESALAMINE EXTENDED-RELEASE CAPSULES. MESALAMINE extended-release capsules, for oral use Initial U.S. Approval: 1987 | Product name | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2023-10-26 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE delayed-release tablets, for oral use Initial U.S. Approval: 1987 | Product name | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2023-08-11 |
| These highlights do not include all the information needed to use MESALAMINE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MESALAMINE EXTENDED-RELEASE CAPSULES. MESALAMINE extended-release capsules, for oral use Initial U.S. Approval: 1987 | Product name | Alembic Pharmaceuticals Limited | 2022-11-07 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. Mesalamine delayed-release tablets, for oral use Initial U.S. Approval: 1987 | Product name | A-S Medication Solutions | 2021-03-04 |
| These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE Delayed-release Tablets, for oral use Initial U.S. Approval: 1987 | Product name | A-S Medication Solutions | 2021-03-03 |
| PENTASA ® (mesalamine) Controlled-Release Capsules 250 mg and 500 mg Prescribing Information as of 10/2015 Rx only | Product name | Carilion Materials Management | 2016-08-06 |
| These highlights do not include all the information needed to use DELZICOL ® safely and effectively. See full prescribing information for DELZICOL. DELZICOL ® (mesalamine) delayed-release capsules, for oral use Initial U.S. Approval: 1987 | Product name | Carilion Materials Management | 2016-08-06 |
| PENTASA ® (mesalamine) Controlled-Release Capsules 250 mg Prescribing Information as of 10/2015 Rx only | Product name | Avera McKennan Hospital | 2016-01-05 |
| Asacol ® (mesalamine) Delayed-Release Tablets | Product name | State of Florida DOH Central Pharmacy | 2014-03-07 |
| These highlights do not include all the information needed to use APRISO safely and effectively. See full prescribing information for APRISO. APRISO™ (mesalamine) extended-release capsules Initial U.S. Approval: 1987 | Product name | Physicians Total Care, Inc. | 2012-02-15 |
| Physicians Total Care, Inc. human prescription drug label | Product name | Physicians Total Care, Inc. | 2010-08-23 |
| Asacol ® (mesalamine) Delayed-Release Tablets | Product name | State of Florida DOH Central Pharmacy | 2010-03-12 |