| 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 | ANI Pharmaceuticals, Inc. | 20260520 | 3 |
| 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 | KLM Laboratories Private Limited | 20260401 | 5 |
| 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 | Takeda Pharmaceuticals America, Inc. | Sharp Packaging Services LLC | PharmaZell GmbH | Cosmo SpA | PharmaZell (India) Private Ltd. | 20260324 | 49 |
| 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 | Golden State Medical Supply, Inc. | 20260305 | 1 |
| 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 | Actavis Pharma, Inc. | 20260224 | 9 |
| 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 | AvKARE | 20260114 | 2 |
| 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 | Chartwell RX, LLC | 20251217 | 3 |
| 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 | Camber Pharmaceuticals, Inc. | Annora Pharma Private Limited | 20251210 | 2 |
| 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 | Rising Pharma Holdings, Inc. | Bliss GVS Pharma Limited | 20251210 | 2 |
| 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 | Ingenus Pharmaceuticals, LLC | Novast Laboratories, Ltd. | 20251205 | 2 |
| 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 | Upsher-Smith Laboratories, LLC | AMTA LABS LIMITED | Yichang Humanwell Oral Solid Dosage Plant | 20251201 | 4 |
| 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 | Encube Ethicals, Inc. | Encube Ethicals Private Limited | 20251007 | 6 |
| 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 | Major Pharmaceuticals | 20250915 | 7 |
| 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 | Teva Pharmaceuticals USA, Inc. | 20250530 | 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 Initial U.S. Approval: 1987 | American Health Packaging | 20250521 | 4 |
| 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 | Actavis Pharma, Inc. | 20250327 | 25 |
| 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 | Takeda Pharmaceuticals America, Inc. | Patheon Manufacturing Services LLC | PharmaZell GmbH | Syntese A/S | Sharp Packaging Services, LLC | 20250115 | 42 |
| 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 | Northstar Rx LLC. | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 20250110 | 5 |
| 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 | AvPAK | 20250109 | 2 |
| MESALAMINE SUPPOSITORIES | Zydus Lifesciences Limited | 20250109 | 7 |
| 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 | Takeda Pharmaceuticals America, Inc. | Cosmo SpA | Sharp Packaging Services, LLC | PharmaZell GmbH | PharmaZell (India) Private Ltd. | 20250109 | 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 | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 20250108 | 7 |
| MESALAMINE DELAYED-RELEASE TABLETS | Zydus Lifesciences Limited | 20241130 | 7 |
| MESALAMINE DELAYED-RELEASE TABLETS | Zydus Lifesciences Limited | 20241130 | 7 |
| MESALAMINE Extended-Release Capsules | Zydus Lifesciences Limited | 20241130 | 3 |
| 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 | American Health Packaging | 20241122 | 7 |
| 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 | NorthStar RxLLC | Annora Pharma Private Limited | 20241121 | 1 |
| 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 | American Health Packaging | 20241121 | 6 |
| 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 | American Health Packaging | 20241114 | 5 |
| Mesalamine Rectal Suspension, USP Enema | Bryant Ranch Prepack | 20241107 | 106 |
| Mesalamine Rectal Suspension, USP Enema | Bryant Ranch Prepack | 20241107 | 106 |
| 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 | Bryant Ranch Prepack | 20241101 | 101 |
| 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 | Allergan, Inc. | 20240908 | 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 | Sun Pharmaceutical Industries Inc. | Sun Pharmaceutical Industries Limited | 20240827 | 11 |
| 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 | Bryant Ranch Prepack | 20240814 | 102 |
| 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 | Padagis Israel Pharmaceuticals Ltd | 20240801 | 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 | Padagis Israel Pharmaceuticals Ltd | 20240801 | 8 |
| 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 | Padagis Israel Pharmaceuticals Ltd | 20240801 | 14 |
| 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 | Viatris Specialty LLC | 20240724 | 12 |
| 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 | Viatris Specialty LLC | 20240715 | 17 |
| 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 | Ascend Laboratories, LLC | Alkem Laboratories Limited | 20240703 | 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 | Teva Pharmaceuticals, Inc. | 20240628 | 1 |
| 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 | Bryant Ranch Prepack | 20240628 | 103 |
| 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 | Rising Pharma Holdings, Inc. | Halo Pharmaceuticals, Inc. | 20240614 | 11 |
| 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 | Bryant Ranch Prepack | 20240529 | 101 |
| 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 | Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals of New York, LLC | 20240523 | 10 |
| Mesalamine Rectal Suspension, USP Enema 4 grams/unit (60 mL) | Bryant Ranch Prepack | 20240501 | 101 |
| 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 | Golden State Medical Supply, Inc. | 20240426 | 1 |
| 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 | Lannett Company Inc. | Sinotherapeutics Inc. | Haimen Pharma Inc. | 20240229 | 7 |
| 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 | Camber Pharmaceuticals, Inc. | Annora Pharma Private Limited | 20240226 | 4 |
| 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 | Camber Pharmaceuticals, Inc. | Annora Pharma Private Limited | 20240215 | 1 |
| Mesalamine Rectal Suspension Enema 4 grams/unit (60 mL) | ANI Pharmaceuticals, Inc. | 20240214 | 9 |
| 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 | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 20240120 | 5 |
| 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 | Salix Pharmaceuticals, Inc. | Catalent Pharma Solutions, LLC | Bausch Health Companies Inc. | 20240109 | 34 |
| 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 | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | 20240109 | 7 |
| 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 | Teva Pharmaceuticals USA, Inc. | Catalent Pharma Solutions, LLC | Bausch Health Companies Inc. | 20231219 | 8 |
| 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 | Amring Pharmaceuticals Inc. | Confab Laboratories Inc. | 20231215 | 7 |
| 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 | Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited | 20231201 | 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 | Mylan Pharmaceuticals Inc. | 20231130 | 5 |
| 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 | Oceanside Pharmaceuticals | Catalent Pharma Solutions, LLC | Bausch Health Companies Inc. | 20231031 | 9 |
| 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 | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 20231026 | 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, for oral use Initial U.S. Approval: 1987 | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 20231026 | 4 |
| 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 | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 20230811 | 8 |
| 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 | Alembic Pharmaceuticals Limited | 20221107 | 1 |
| 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 | A-S Medication Solutions | 20210304 | 7 |
| 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 | A-S Medication Solutions | 20210303 | 1 |
| PENTASA ® (mesalamine) Controlled-Release Capsules 250 mg and 500 mg Prescribing Information as of 10/2015 Rx only | Carilion Materials Management | 20160806 | 3 |
| 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 | Carilion Materials Management | 20160806 | 3 |
| PENTASA ® (mesalamine) Controlled-Release Capsules 250 mg Prescribing Information as of 10/2015 Rx only | Avera McKennan Hospital | 20160105 | 1 |
| Asacol ® (mesalamine) Delayed-Release Tablets | State of Florida DOH Central Pharmacy | 20140307 | 2 |
| 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 | Physicians Total Care, Inc. | 20120215 | 2 |
| 357e0e6b-cfbd-454c-82d7-cfc460dc0d68 | Physicians Total Care, Inc. | 20100823 | 1 |
| Asacol ® (mesalamine) Delayed-Release Tablets | State of Florida DOH Central Pharmacy | 20100312 | 2 |