| These highlights do not include all the information needed to use FYARRO safely and effectively. See full prescribing information for FYARRO. FYARRO ® (sirolimus protein-bound particles for injectable suspension) (albumin-bound), for intravenous use Initial U.S. Approval: 2021 | Aadi Bioscience, Inc. | 20260519 | 9 |
| These highlights do not include all the information needed to use SIROLIMUS TABLETS safely and effectively. See full prescribing information for SIROLIMUS TABLETS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 1999 | NORTHSTAR RX LLC | Glenmark Pharmaceuticals Ltd. | 20260511 | 4 |
| These highlights do not include all the information needed to use SIROLIMUS ORAL SOLUTION safely and effectively. See full prescribing information for SIROLIMUS ORAL SOLUTION. SIROLIMUS oral solution Initial U.S. Approval: 1999 | Bryant Ranch Prepack | 20260506 | 100 |
| These highlights do not include all the information needed to use SIROLIMUS safely and effectively. See full prescribing information for SIROLIMUS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 1999 | Mylan Pharmaceuticals Inc. | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | Wyeth Pharmaceutical Division of Wyeth Holdings LLC | Pfizer Manufacturing Deutschland GmbH | Pfizer Ireland Pharmaceuticals Unlimited Company | 20260326 | 22 |
| Sirolimus Tablets These highlights do not include all the information needed to use SIROLIMUS TABLETS safely and effectively. See full prescribing information for SIROLIMUS TABLETS . SIROLIMUS tablets, for oral use Initial U.S. Approval: 1999 | AvPAK | 20260310 | 21 |
| These highlights do not include all the information needed to use SIROLIMUS TABLETS safely and effectively. See full prescribing information for SIROLIMUS TABLETS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 1999 | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Ltd. | 20260128 | 4 |
| These highlights do not include all the information needed to use SIROLIMUS TABLETS safely and effectively. See full prescribing information for SIROLIMUS TABLETS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 1999 | Major Pharmaceuticals | 20251110 | 4 |
| These highlights do not include all the information needed to use SIROLIMUS ORAL SOLUTION safely and effectively. See full prescribing information for SIROLIMUS ORAL SOLUTION. SIROLIMUS oral solution Initial U.S. Approval: 1999 | Rising Pharma Holdings, Inc. | Cohance Lifesciences Limited | 20251008 | 5 |
| These highlights do not include all the information needed to use SIROLIMUS ORAL SOLUTION safely and effectively. See full prescribing information for SIROLIMUS ORAL SOLUTION. SIROLIMUS oral solution Initial U.S. Approval: 1999 | Apotex Corp | Apotex Inc | 20250922 | 6 |
| These highlights do not include all the information needed to use SIROLIMUS TABLETS safely and effectively. See full prescribing information for SIROLIMUS TABLETS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 1999 | Ascend Laboratories, LLC | Alkem Laboratories Limited | 20250918 | 8 |
| These highlights do not include all the information needed to use SIROLIMUS ORAL SOLUTION safely and effectively. See full prescribing information for SIROLIMUS ORAL SOLUTION. SIROLIMUS oral solution Initial U.S. Approval: 1999 | Northstar Rx LLC | MSN Pharmaceuticals Inc. | 20250829 | 1 |
| These highlights do not include all the information needed to use HYFTOR ® safely and effectively. See full prescribing information for HYFTOR. HYFTOR ® (sirolimus topical gel) Initial U.S. Approval: 1999 | Nobelpharma America, LLC | Sharp Clinical, Inc | Toyo Pharmaceutical Co., Ltd. | 20250822 | 10 |
| These highlights do not include all the information needed to use SIROLIMUS TABLETS safely and effectively. See full prescribing information for SIROLIMUS TABLETS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 1999 | American Health Packaging | 20250820 | 9 |
| These highlights do not include all the information needed to use SIROLIMUS TABLETS safely and effectively. See full prescribing information for SIROLIMUS TABLETS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 1999 | REMEDYREPACK INC. | 20250819 | 1 |
| These highlights do not include all the information needed to use SIROLIMUS TABLETS safely and effectively. See full prescribing information for SIROLIMUS TABLETS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 1999 | REMEDYREPACK INC. | 20250724 | 4 |
| These highlights do not include all the information needed to use SIROLIMUS TABLETS safely and effectively. See full prescribing information for SIROLIMUS TABLETS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 1999 | REMEDYREPACK INC. | 20250630 | 1 |
| These highlights do not include all the information needed to use SIROLIMUS safely and effectively. See full prescribing information for SIROLIMUS. SIROLIMUS oral solution Initial U.S. Approval: 1999 | Mylan Pharmaceuticals Inc. | Wyeth Pharmaceutical Division of Wyeth Holdings LLC | 20250527 | 17 |
| These highlights do not include all the information needed to use SIROLIMUS ORAL SOLUTION safely and effectively. See full prescribing information for SIROLIMUS ORAL SOLUTION. SIROLIMUS oral solution Initial U.S. Approval: 1999 | Novadoz Pharmaceuticals LLC | MSN Pharmaceuticals Inc. | 20250321 | 3 |
| These highlights do not include all the information needed to use SIROLIMUS ORAL SOLUTION safely and effectively. See full prescribing information for SIROLIMUS ORAL SOLUTION. SIROLIMUS oral solution Initial U.S. Approval: 1999 | Camber Pharmaceuticals, Inc. | Annora Pharma Private Limited | 20241127 | 1 |
| These highlights do not include all the information needed to use SIROLIMUS ORAL SOLUTION safely and effectively. See full prescribing information for SIROLIMUS ORAL SOLUTION. SIROLIMUS oral solution Initial U.S. Approval: 1999 | VistaPharm, LLC | 20240430 | 11 |
| These highlights do not include all the information needed to use SIROLIMUS TABLETS safely and effectively. See full prescribing information for SIROLIMUS TABLETS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 1999 | Dr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited - FTO 7 | 20230930 | 17 |
| SIROLIMUS TABLETS | Zydus Lifesciences Limited | 20230927 | 11 |
| These highlights do not include all the information needed to use SIROLIMUS TABLETS safely and effectively. See full prescribing information for SIROLIMUS TABLETS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 1999 | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 20230720 | 16 |
| These highlights do not include all the information needed to use SIROLIMUS ORAL SOLUTION safely and effectively. See full prescribing information for SIROLIMUS ORAL SOLUTION. SIROLIMUS oral solution Initial U.S. Approval: 1999 | Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals, LLC | 20221222 | 16 |