MIRABEGRON Pharmacologic Class Indexing
- Class set ID
- 948dc6c4-9848-4e7b-a451-fa00f3f8cf4a
- Version
- 3
- Effective date
- 20210512
- Type
- Indexing - Pharmacologic Class
Mapped DailyMed Labels#
Label, Manufacturer, Effective table| Label | Manufacturer | Effective | SPL version |
|---|
| These highlights do not include all the information needed to use MIRABEGRON EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MIRABEGRON EXTENDED-RELEASE TABLETS. MIRABEGRON extended-release tablets, for oral use Initial U.S. Approval: 2012 | REMEDYREPACK INC. | 20260522 | 1 |
| These highlights do not include all the information needed to use MIRABEGRON EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MIRABEGRON EXTENDED-RELEASE TABLETS MIRABEGRON extended-release tablets, for oral use Initial U.S. Approval: 2012 | REMEDYREPACK INC. | 20260427 | 1 |
| These highlights do not include all the information needed to use MIRABEGRON EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MIRABEGRON EXTENDED-RELEASE TABLETS. MIRABEGRON extended-release tablets, for oral use Initial U.S. Approval: 2012 | Amneal Pharmaceuticals NY LLC | 20260326 | 4 |
| These highlights do not include all the information needed to use MIRABEGRON FOR EXTENDED-RELEASE ORAL SUSPENSION safely and effectively. See full prescribing information for MIRABEGRON FOR EXTENDED-RELEASE ORAL SUSPENSION. MIRABEGRON for extended-release oral suspension Initial U.S. Approval: 2012 | Ascend Laboratories, LLC | Alkem Laboratories Limited | 20260318 | 6 |
| These highlights do not include all the information needed to use MIRABEGRON EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MIRABEGRON EXTENDED-RELEASE TABLETS. MIRABEGRON extended-release tablets, for oral use Initial U.S. Approval: 2012 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251224 | 19 |
| These highlights do not include all the information needed to use MIRABEGRON EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MIRABEGRON EXTENDED-RELEASE TABLETS. MIRABEGRON extended-release tablets, for oral use Initial U.S. Approval: 2012 | Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park) | 20251021 | 1 |
| These highlights do not include all the information needed to use MIRABEGRON EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MIRABEGRON EXTENDED-RELEASE TABLETS MIRABEGRON extended-release tablets, for oral use Initial U.S. Approval: 2012 | REMEDYREPACK INC. | 20251002 | 3 |
| These highlights do not include all the information needed to use MIRABEGRON EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MIRABEGRON EXTENDED-RELEASE TABLETS. MIRABEGRON extended-release tablets, for oral use Initial U.S. Approval: 2012 | Bryant Ranch Prepack | 20250926 | 100 |
| These highlights do not include all the information needed to use MIRABEGRON EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MIRABEGRON EXTENDED-RELEASE TABLETS. MIRABEGRON extended-release tablets, for oral use Initial U.S. Approval: 2012 | Bryant Ranch Prepack | 20250926 | 100 |
| These highlights do not include all the information needed to use MIRABEGRON EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MIRABEGRON EXTENDED-RELEASE TABLETS. MIRABEGRON extended-release tablets, for oral use Initial U.S. Approval: 2012 | Bryant Ranch Prepack | 20250926 | 100 |
| These highlights do not include all the information needed to use MIRABEGRON EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MIRABEGRON EXTENDED-RELEASE TABLETS. MIRABEGRON extended-release tablets, for oral use Initial U.S. Approval: 2012 | Bryant Ranch Prepack | 20250926 | 100 |
| These highlights do not include all the information needed to use MIRABEGRON EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MIRABEGRON EXTENDED-RELEASE TABLETS MIRABEGRON extended-release tablets, for oral use Initial U.S. Approval: 2012 | Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Limited | 20241009 | 3 |
| These highlights do not include all the information needed to use MIRABEGRON EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MIRABEGRON EXTENDED-RELEASE TABLETS MIRABEGRON extended-release tablets, for oral use Initial U.S. Approval: 2012 | Zydus Lifesciences Limited | 20241009 | 3 |
| These highlights do not include all the information needed to use MYRBETRIQ ® /MYRBETRIQ ® GRANULES safely and effectively. See full prescribing information for MYRBETRIQ/MYRBETRIQ GRANULES. MYRBETRIQ (mirabegron extended-release tablets), for oral use MYRBETRIQ GRANULES (mirabegron for extended-release oral suspension) Initial U.S. Approval: 2012 | Astellas Pharma US, Inc. | Astellas Pharma Inc. | Sumitomo Chemical Company, Limited | Astellas Ireland Co., Ltd. | Delpharm Meppel B.V. | 20240801 | 17 |